Immunogenicity & Safety of GSK's Avian Flu Vaccine 1557484A Given to Adults Aged ≥18 Years

Influenza Clinical Trial

Official title:

A Trial to Evaluate the Safety and Immunogenicity of Monovalent H5N1 Vaccine in Adults >=18 Yrs of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00719043
• Other study ID #: 110624
• Status: Completed
• Phase: Phase 2
• Start date: July 11, 2008
• Est. completion date: February 18, 2011

Study information

• Verified date: May 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether GSK's avian flu vaccine GSK 1557484A is immunogenic and safe when given to adults aged >=18 years.

This Protocol Posting has been updated following Amendments 1-3 of the Protocol, Dec 2009. The impacted sections are study design and outcome measures.

Description:

All subjects will receive 3 doses of study vaccine, including 2 doses of active vaccine and 1 dose of placebo. All subjects will attend formal study center visits for safety and immunogenicity assessments on Days 0, 10, 42, 182, 192, 224, 549, 559, 591, and 729. A telephone contact to assess safety will be made at Day 364 and Day 909.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 841
• Est. completion date: February 18, 2011
• Est. primary completion date: April 22, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• A male or female 18 years of age or older at the time of the first vaccination.

• Written informed consent obtained from the subject.

• Stable health status as defined by absence of a health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within 1 month prior to enrollment.

• Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device.

• Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.

• Subjects who the investigator believes can and will comply with the requirements of the protocol

Exclusion Criteria:

• Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.

• Diagnosed with cancer, or treatment for cancer, within 3 years.

• Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.

• Persons with a history of histologically-confirmed basal cell carcinoma of the skin successfully treated with local excision only are excepted and may enroll within 3 years of diagnosis, but other histologic types of skin cancer require a 3 year untreated and disease-free window as above.

• Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylactic tamoxifen are excepted and may enroll.

• Presence of an oral temperature = 37.8ºC, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.

• Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.

• Receipt of systemic glucocorticoids (prednisone >= 10 mg/day for more than 14 consecutive days) within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment.

• Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.

• Administration of any vaccines within 30 days before the first study vaccine dose.

• Previous administration of any H5N1 vaccine.

• Use of any investigational or non-registered product (drug or vaccine) or planned participation in another investigational study within 30 days prior to study enrollment, or during the 18 months following the first test article dose. Use of any investigational or non-registered product with immunosuppressive properties is exclusionary at any time during the trial.

• Receipt of any immunoglobulins and/or any blood products within 6 months of study enrollment or planned administration of any of these products during the study period.

• Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins or mercurial preservatives); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.

• Known pregnancy or a positive urine beta-human chorionic gonadotropin (ß-hCG) test result prior to vaccination.

• Lactating or nursing.

• Women of child bearing potential who lack a history of reliable contraceptive practices. The provision of this history does NOT replace the requirement to perform, and obtain negative results in pregnancy urine tests prior to treatments.

• Known receipt of analgesic or antipyretic medication with the specific intent of prophylaxis of vaccine reactogenicity on the day of first or any treatment. Subjects on stable chronic regimens of potentially analgesic or anti-pyretic medications for pre-existing diagnoses are not required to discontinue them (to do so would represent evaluation of combined vaccine reactogenicity AND treatment withdrawal - which is not the intent of the protocol).

Related Conditions & MeSH terms

• Influenza

Intervention

Biological:
• A/turkey H5N1 vaccine
Administered as an intramuscular (IM) injection
• Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia)
Administered as an intramuscular (IM) injection
• Placebo
Administered as an intramuscular (IM) injection

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Halifax	Nova Scotia
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Sherbrooke	Quebec
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Bristol	Tennessee
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Fort Worth	Texas
United States	GSK Investigational Site	Kansas City	Missouri
United States	GSK Investigational Site	Metairie	Louisiana
United States	GSK Investigational Site	Milford	Massachusetts
United States	GSK Investigational Site	Missoula	Montana
United States	GSK Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (=) 1:40 or a pre-vaccination reciprocal titer = 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 549. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.	At Day 559
Primary	Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (=) 1:40 or a pre-vaccination reciprocal titer = 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group	At Day 192
Primary	Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.	HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.	At Days 549 and 559
Primary	Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.	HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.	At Days 182 and 192
Primary	Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.	A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (=) 1:40. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.	At Days 549 and 559
Primary	Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.	A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (=) 1:40. This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.	At Days 182 and 192
Primary	Number of Subjects With Solicited Local Symptoms	Assessed solicited local symptoms were pain, redness and swelling. Any was defined as an occurrence of the specified solicited local symptom regardless of its intensity.	Within the 7-day (Days 0-6) post vaccination periods
Primary	Number of Subjects With Solicited General Symptoms	Solicited general symptoms assessed were fatigue, headache, joint pain at other locations (joint pain), muscle aches, shivering, sweating and fever. Any was defined as an occurrence of the specified solicited general symptom, irrespective of its intensity or relationship to vaccination. Any fever was defined as oral temperature higher than or equal to (=) 38.0 degrees Celsius (°C).	Within the 7-day (Days 0-6) post vaccination periods
Primary	Number of Subjects With Medically-attended Adverse Events (MAEs)	MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).	From Day 0 to Day 909
Primary	Number of Subjects With Unsolicited Adverse Events (AEs)	An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as any occurrence of an unsolicited AE in a subject, regardless of intensity grade or relation to vaccination.	Within the 43-day (Days 0-42) post-vaccination periods
Primary	Number of Subjects With Serious Adverse Events (SAEs)	A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as an occurrence of an SAE, regardless its relationship to vaccination.	From Day 0 to Day 909
Secondary	Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (=) 1:40 or a pre-vaccination reciprocal titer = 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.	At Day 192
Secondary	Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey Virus Strain.	HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.	At Days 182 and 192
Secondary	Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.	A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (=) 1:40. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.	At Days 182 and 192
Secondary	Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.	A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (=) 1:40. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.	At Day 224
Secondary	Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.	A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (=) 1:40. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.	At Day 591
Secondary	Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain	GMFR was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the baseline reciprocal HI titer. Baseline for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.	At Days 192 and 224
Secondary	Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain	GMFR was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the baseline reciprocal HI titer. Baseline for this outcome measure corresponds to Day 549. This outcome measure solely concerns subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.	At Day 559
Secondary	Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (=) 1:40 or a pre-vaccination reciprocal titer = 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 549. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.	At Day 591
Secondary	Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (=) 1:40 or a pre-vaccination reciprocal titer = 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.	At Day 224
Secondary	Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.	HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.	At Days 0, 182,192, 224, 549 and 729
Secondary	Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.	HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.	At Days 0, 182, 549, 559, 591 and 729
Secondary	Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.	HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.	At Days 0, 182, 192, 224, 549, 559, 591 and 729
Secondary	Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain.	A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (=) 1:40. This outcome measure concerns solely the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.	At Days 0, 182,192, 224, 549 and 729
Secondary	Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain	A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (=) 1:40. This outcome measure concerns solely the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.	At Days 0, 182, 549, 559, 591 and 729
Secondary	Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain	A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (=) 1:40. This outcome measure concerns solely the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.	At Days 0, 182, 192, 224, 549, 559, 591 and 729
Secondary	Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain.	HI antibody titers against the A/Indo virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.	At Days 0, 10, 42, 182 and 549
Secondary	Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain.	HI antibody titers against the A/Indo virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.	At Days 0, 10, 42, 182, 549 and 559
Secondary	Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain.	A seroprotected subject was defined as a vaccinated subject with HI antibody reciprocal titers against the A/Indo virus strain greater than or equal to (=) 1:40. This outcome measure solely concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.	At Day 0, Day 10, Day 42, Day 182 and Day 549
Secondary	Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain.	A seroprotected subject was defined as a vaccinated subject with HI antibody reciprocal titers against the A/Indo virus strain greater than or equal to (=) 1:40. This outcome measure solely concerns the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.	At Day 0, Day 10, Day 42, Day 182, Day 549, and Day 559
Secondary	Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain.	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (=) 1:40 or a pre-vaccination reciprocal titer = 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 0.; This outcome measure only concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.	At Days 10 and 42
Secondary	Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain.	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (=) 1:40 or a pre-vaccination reciprocal titer = 1:10 and at least a 4-fold increase in post-vaccination titer. This outcome measure only concerns the Naïve Placebo-A/turkey H5N1-Formulation 3 Group, for whom the pre-vaccination time point corresponds to the Day 192 time point.	At Days 192 and 224

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