Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

Vaccines, Pneumococcal Clinical Trial

Official title:

A Phase 3, Randomized, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United Kingdom

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00384059
• Other study ID #: 6096A1-007
• Status: Completed
• Phase: Phase 3
• First received: October 2, 2006
• Last updated: January 22, 2013
• Start date: October 2006
• Est. completion date: October 2008

Study information

• Verified date: January 2013
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccines in the United Kingdom.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 42 Days to 98 Days

Eligibility

Inclusion Criteria:

1. Aged 2 months (42 to 98 days) at the time of enrollment.

2. Available for entire study period and whose parent(s)/legal guardian(s) could be reached by telephone.

3. Healthy infant, as determined by medical history, physical examination, and judgment of the investigator.

4. Parent(s)/legal guardian(s) had to be able to complete all relevant study procedures during study participation.

Exclusion Criteria:

1. Previous vaccination with licensed or investigational pneumococcal vaccine.

2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or meningococcal vaccines.

3. A previous anaphylactic reaction to any vaccine or vaccine-related component.

4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, pneumococcal conjugate, or meningococcal conjugate vaccines.

5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.

6. Known or suspected immune deficiency or suppression.

7. History of culture-proven invasive disease caused by S pneumoniae, Neisseria meningitidis, or Hib.

8. Major known congenital malformation or serious chronic disorder.

9. Significant neurological disorder or history of seizure, including febrile seizure, or significant stable or evolving disorders, such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. This did not include resolving syndromes due to birth trauma such as Erb palsy.

10. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®).

11. Participation in another investigational trial. Participation in purely observational studies was acceptable.

12. Infant who was a direct descendant (eg, child or grandchild) of the study site personnel.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Vaccines, Pneumococcal

Intervention

Biological:
• 13-valent Pneumococcal Conjugate Vaccine
Single 0.5 mL dose given at 2, 3, 4, and 12 months of age
• 7vPnC
Single 0.5 mL dose given at 2, 3, 4 and 12 months of age
• Pediacel
concommitant vaccine, both at arm 1 and at arm 2, at 2 months, 3 months and 4 months of age
• NeisVac-C
concomittant vaccine, both at arm 1 and at arm 2, at 2 months and 4 months of age
• Menitorix
concomitant vaccine, both at arm 1 and at arm 2, at 12 months of age

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Participants Reporting Pre-Specified Local Reactions	Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.	During the 4-day period after each dose	Yes
Other	Percentage of Participants Reporting Pre-Specified Systemic Events	Systemic events (fever = 38 degrees Celsius [C] but = 39 C, fever >39 C but = 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, use of medication (Meds) to prevent symptoms, and use of medication to treat symptoms) were collected using an electronic diary; percentage of participants with each event was evaluated.	During the 4-day period after each dose	Yes
Primary	Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer =1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series.	Percentage of participants achieving a meningococcal C SBA serum antibody titer =1:8 and predefined antibody threshold levels with the corresponding 95% CI for concomitant antigens polyribosylribitol phosphate (PRP) in haemophilus influenzae type b [Hib](=0.15 µg/mL or = 1.0 µg/mL), pertussis toxoid [PT], filamentous haemagglutinin, pertactin [FHA], and pertactin (PRN) (=5 Elisa Units EU/mL) and fimbrial agglutinogens [FIM] (=2.2 EU/mL) are presented.	One month after infant series dose 2 (5 months of age)	No
Primary	Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series		one month after infant series dose 2 (5 months of age)	No
Primary	Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series		one month after infant series dose 2 (5 months of age)	No
Primary	Geometric Mean Antibody Concentration of Pertusis Filamentous Haemagglutinin (FHA), Pertussis Toxoid (PT), Pertactin (PRN), and Fimbrial Agglutinogens (FIM) as Measured by ELISA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series		one month after infant series dose 2 (5 months of age)	No
Primary	Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration =0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose	Percentages of participants achieving WHO predefined antibody threshold =0.35µg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.	one month after infant series dose 2 (5 months of age), before and after toddler dose (12 months of age)	No
Primary	Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose.	Antibody concentration/geometric mean concentration (GMC) as measured by ELISA for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented with corresponding 2-sided 95% CI.	one month after infant series dose 2 (5 months of age) and before and after toddler dose (12 months of age)	No
Secondary	Percentage of Participants Achieving an SBA Titer =1:8 for Meningococcal C in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose.		one month after the toddler dose (13 months of age)	No
Secondary	Percentage of Participants Achieving a Predefined Antibody Level for Haemophilus Influenzae Type b in the 13vPnC Group Relative to the 7vPnC Group After the Toddler Dose.		one month after toddler dose (13 months of age)	No
Secondary	Geometric Mean Antibody Concentration for Haemophilus Influenzae Type b PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose.		one month after toddler dose (13 months of age)	No
Secondary	Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose		one month after toddler dose (13 months of age)	No