Immune Memory of DTPw-HBV/Hib Vaccine Following Primary Vaccination, Immuno & Reacto of a Booster Dose Given in Infants

Hepatitis B Clinical Trial

Official title:

Immune Memory of GSK's DTPw-HBV/Hib Vaccine by Giving Plain PRP Polysaccharide at 10 Mths. Immuno & Reacto of a Booster Dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 Mths in Infants Previously Primed With DTPw-HBV/Hib

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00169442
• Other study ID #: 104065
• Status: Completed
• Phase: Phase 3
• Start date: February 10, 2005
• Est. completion date: March 10, 2006

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the immune memory following primary vaccination of DTPw-HBV/Hib vaccine and to assess immunogenicity and reactogenicity of a booster dose given at 15 - 18 months of age.

Description:

• Subjects who received DTPw-HBV/Hib in the primary vaccination without HBV at birth will be randomised (1:3 ratio) to receive either: Plain PRP at 10 months of age followed by DTPw-HBV at 15-18 months of age or DTPw-HBV/Hib at 15-18 months of age.

• Subjects who received DTPw-HBV + Hib in the primary vaccination without HBV at birth will receive DTPw-HBV + Hib as a booster.

• Subjects who received DTPw-HBV/Hib in the primary vaccination with HBV at birth will receive DTPw-HBV/Hib vaccine as a booster.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 745
• Est. completion date: March 10, 2006
• Est. primary completion date: March 1, 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Months to 18 Months

Eligibility

Inclusion criteria:

For subjects receiving Plain PRP followed by DTPw-HBV:

Male or female infant, 10 to 11 months of age, who previously completed the three-dose primary vaccination course with the DTPw-HBV/Hib vaccine.

For subjects receiving DTPw-HBV/Hib or DTPw-HBV + Hib:

Male or female infant, 15-18 months of age, who previously completed the three-dose primary vaccination course with the DTPw-HBV/Hib vaccine.

For all subjects:

• Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol.

• Free of obvious health problems as established by medical history and clinical examination

Exclusion criteria:

• Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding administration of the study vaccine, or planned use during the study period.

• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to administration of the study vaccine.

• Planned administration/administration of a vaccine not foreseen by the study protocol starting 30 days before and ending 30 days after administration of the study vaccine with the exception of oral polio vaccine.

Related Conditions & MeSH terms

• Diphtheria
• Haemophilus Influenzae Type b
• Hepatitis B
• Tetanus
• Whole Cell Pertussis

Intervention

Biological:
• Tritanrix™-HepB/Hiberix™ Kft.
GlaxoSmithKline (GSK) Biologicals Korlatolt Felelossegu Tarsasag [Kft] (Limited Company) combined diphtheria (D), tetanus (T), whole cell Bordetella pertussis (Pw), hepatitis B vaccine with new sources of D, T and Pw antigens mixed with Haemophilus influenzae type b (Hib2.5) vaccine.
• Tritanrix™-HepB/Hiberix™
GSK Biologicals' combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B and Haemophilus Influenzae type b vaccine
• Hiberix™
GSK Biologicals' Haemophilus influenzae type b vaccine
• Polyribosil-Ribitol-Phosphate (PRP) vaccine
plain PRP polysaccharide vaccine
• Tritanrix™-HepB Kft
GSK Biologicals Korlatolt Felelossegu Tarsasag [Kft] (Limited Company) combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B vaccine with new sources of D, T and Pw antigens produced at GSK Biologicals Kft., Gödöllö, Hungary.

Locations

Country	Name	City	State
Philippines	GSK Investigational Site	Muntinlupa
Philippines	GSK Investigational Site	Pasay City
Philippines	GSK Investigational Site	Quezon CIty

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Philippines, 

References & Publications (2)

Gatchalian et al. A new DTPw-HBV/Hib vaccine: Immunogenic and safe for primary vaccination and booster dosing in the second year of life - 5th World Congress WSPID, Bangkok, Thailand, 15-18 Nov 2007

Gatchalian S, Reyes M, Bermal N, Chandrasekaran V, Han HH, Bock HL, Lefevre I. A new DTPw-HBV/Hib vaccine: immune memory after primary vaccination and booster dosing in the second year of life. Hum Vaccin. 2008 Jan-Feb;4(1):60-6. Epub 2007 Sep 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Anti-PRP Antibody Concentrations = 0.15 µg/mL and = 1.0 µg/mL	The number of subjects with anti-PRP antibody concentrations equal to or above (=) 0.15 µg/mL and = 1.0 µg/mL, at one month after the PRP challenge.	At Month 1, post-PRP challenge
Primary	Number of Subjects With Anti-PRP Antibody Concentrations = 0.15 µg/mL and = 1.0 µg/mL.	The number of subjects with anti-PRP antibody concentrations equal to or above (=) 0.15 µg/mL and = 1.0 µg/mL, at one month post-booster vaccination.	At Month 1, post-booster vaccination
Primary	Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)	A seroprotected subject was defined as a vaccinated subject, with anti-D and anti-T antibody concentrations equal to or above (=) 0.1 International Units per milliliter (IU/mL).	At Month 1, post-booster vaccination
Primary	Seroprotection Rates for Anti-D Antibodies	The seroprotection rate is defined as the estimated proportion of subjects with protective antibodies as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) (antibody concentration = 0.1 IU/mL), or by Vero-cell neutralisation assay (antibody concentration = 0.016 IU/mL), for subjects seronegative as assessed by ELISA.	At Month 1, post-booster vaccination
Primary	Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)	A seroprotected subject was defined as a vaccinated subject with an anti-HBs antibody concentration equal to or above (=) 10 milli International Units per milliliter (mIU/mL).	At Month 1, post-booster vaccination
Primary	Number of Seroprotected Subjects Against Bordetella Pertussis (BPT)	A seroprotected subject was defined as a vaccinated subject with an anti-BPT antibody concentration equal to or above (=) 15 ELISA units per milliliter (EL.U/mL).	At Month 1, post-booster vaccination
Primary	Number of Subjects With Booster Response to BPT Antigen	The booster response was defined as: an anti-BPT antibody concentration equal to or above (=) the cut-off value (15 EL.U/mL) at post-booster vaccination in subjects seronegative (anti-BPT antibody concentration < 15 EL.U/mL) prior to administration of the booster dose; or; at least a 2-fold increase in antibody concentration from pre- to post-vaccination time points, in subjects who were seropositive (anti-BPT antibody concentration = 15 EL.U/mL) prior to the administration of the booster dose.	At Month 1, post-booster vaccination
Primary	Anti-PRP Antibody Concentrations	Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (µg/mL), as assessed by ELISA.	At Month 1, post-PRP challenge
Primary	Anti-PRP Antibody Concentrations.	Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (µg/mL), as assessed by ELISA.	At Month 1, post-booster vaccination
Primary	Anti-D and Anti-T Antibody Concentrations	Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International Units per milliliter (IU/mL), as assessed by ELISA.	At Month 1, post-booster vaccination
Primary	Anti-HBs Antibody Concentrations	Anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL), as assessed by ELISA.	At Month 1, post-booster vaccination
Primary	Anti-BPT Antibody Concentrations	Anti-BPT antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL), as assessed by ELISA.	At Month 1, post-booster vaccination
Secondary	Number of Subjects With Anti-PRP Antibody Concentrations = 0.15 µg/mL and = 1.0 µg/mL	The number of subjects with anti-PRP antibody concentrations equal to or above (=) 0.15 µg/mL and = 1.0 µg/mL, prior to the PRP challenge.	At Month 0, prior to the PRP challenge
Secondary	Number of Subjects With Anti-PRP Antibody Concentrations = 0.15 µg/mL and = 1.0 µg/mL.	The number of subjects with anti-PRP antibody concentrations equal to or above (=) 0.15 µg/mL and = 1.0 µg/mL, prior to the booster vaccination.	At Month 0, prior to the PRP challenge
Secondary	Number of Subjects With Anti-D and Anti-T Antibody Concentrations = the Cut-off Value	The number of subjects with anti-D antibody concentrations equal to or above (=) the cut-off value of 0.1 IU/mL as assessed by ELISA, (or = 0.016 IU/mL as assessed by the neutralisation assay on Vero cells in subjects seronegative by ELISA testing) and, the number of subjects with anti-T antibody concentrations = the cut-off value of 0.1 IU/mL as assessed by ELISA.	At Month 0, prior to the PRP challenge
Secondary	Seroprotection Rates for Anti-D Antibodies	The seroprotection rate is defined as the estimated proportion of subjects with protective antibodies as assessed by ELISA (antibody concentration = 0.1 IU/mL), or by Vero-cell neutralisation assay (antibody concentration = 0.016 IU/mL), for subjects seronegative as assessed by ELISA.	At Month 0, prior to the PRP challenge
Secondary	Number of Subjects With Anti-HBs Antibody Concentrations = the Cut-off Value	The number of subjects with anti-HBs antibody concentrations equal to or above (=) the cut-off value of 10 mIU/mL, prior to the booster vaccination.	At Month 0, prior to the PRP challenge
Secondary	Number of Subjects With Anti-BPT Antibody Concentrations = the Cut-off Value	The number of subjects with anti-BPT antibody concentrations equal to or above (=) the cut-off value of 15 EL.U/mL, prior to the booster vaccination.	At Month 0, prior to the PRP challenge
Secondary	Anti- PRP Antibody Concentrations	Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (µg/mL), as assessed by ELISA.	At Month 0, prior to the PRP challenge
Secondary	Anti- PRP Antibody Concentrations.	Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (µg/mL), as assessed by ELISA.	At Month 0, prior to the PRP challenge
Secondary	Anti-D and Anti-T Antibody Concentrations.	Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International Units per milliliter (IU/mL), as assessed by ELISA.	At Month 0, prior to the PRP challenge
Secondary	Anti-HBs Antibody Concentrations.	Anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL), as assessed by ELISA.	At Month 0, prior to the PRP challenge
Secondary	Anti-BPT Antibody Concentrations.	Anti-BPT antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL), as assessed by ELISA.	At Month 0, prior to the PRP challenge
Secondary	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.	During the 4-Day (Days 0-3) post-PRP challenge
Secondary	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (=) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Grade 3 irritability = crying that could not be comforted and prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination.	During the 4-Day (Days 0-3) post-PRP challenge
Secondary	Number of Subjects With Any and Grade 3 Solicited Local Symptoms.	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.	During the 4-Day (Days 0-3) post-booster vaccination period
Secondary	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.	Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (=) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Grade 3 irritability = crying that could not be comforted and prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination.	During the 4-Day (Days 0-3) post-booster vaccination period
Secondary	Number of Subjects With Unsolicited Adverse Events (AEs)	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.	During the 31-Day (Day 0-30) follow-up period
Secondary	Number of Subjects With Serious Adverse Events (SAEs)	SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.	During the entire study period (from Month 0 to Month 9.5)

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.