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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

745 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-10

Study Completion Date

2006-03-10

Brief Summary

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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.

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Detailed Description

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* 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.

Conditions

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Whole Cell Pertussis Diphtheria Hepatitis B Tetanus Haemophilus Influenzae Type b

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Tritanrix-HepB/Hiberix Kft. Mix Group

Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.

Group Type EXPERIMENTAL

Tritanrix™-HepB/Hiberix™ Kft.

Intervention Type BIOLOGICAL

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 Kft. Ref Group

Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.

Group Type EXPERIMENTAL

Tritanrix™-HepB/Hiberix™ Kft.

Intervention Type BIOLOGICAL

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™

Intervention Type BIOLOGICAL

GSK Biologicals' combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B and Haemophilus Influenzae type b vaccine

HB Tritanrix-HepB/Hiberix Kft. Mix Group

Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.

Group Type EXPERIMENTAL

Tritanrix™-HepB/Hiberix™ Kft.

Intervention Type BIOLOGICAL

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 Kft.+Hiberix Group

Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age.

Group Type EXPERIMENTAL

Hiberix™

Intervention Type BIOLOGICAL

GSK Biologicals' Haemophilus influenzae type b vaccine

Tritanrix™-HepB Kft

Intervention Type BIOLOGICAL

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.

PRP Tritanrix-HepB Kft. Mix Group

Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain Polyribosil-Ribitol-Phosphate (PRP) polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.

Group Type EXPERIMENTAL

Tritanrix™-HepB/Hiberix™ Kft.

Intervention Type BIOLOGICAL

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.

Polyribosil-Ribitol-Phosphate (PRP) vaccine

Intervention Type BIOLOGICAL

plain PRP polysaccharide vaccine

Tritanrix™-HepB Kft

Intervention Type BIOLOGICAL

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.

PRP Tritanrix-HepB Kft. Ref Group

Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain Polyribosil-Ribitol-Phosphate (PRP) polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age.

Group Type EXPERIMENTAL

Tritanrix™-HepB/Hiberix™

Intervention Type BIOLOGICAL

GSK Biologicals' combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B and Haemophilus Influenzae type b vaccine

Polyribosil-Ribitol-Phosphate (PRP) vaccine

Intervention Type BIOLOGICAL

plain PRP polysaccharide vaccine

Tritanrix™-HepB Kft

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

Tritanrix™-HepB/Hiberix™

GSK Biologicals' combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B and Haemophilus Influenzae type b vaccine

Intervention Type BIOLOGICAL

Hiberix™

GSK Biologicals' Haemophilus influenzae type b vaccine

Intervention Type BIOLOGICAL

Polyribosil-Ribitol-Phosphate (PRP) vaccine

plain PRP polysaccharide vaccine

Intervention Type BIOLOGICAL

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.

Intervention Type BIOLOGICAL

Other Intervention Names

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DTPw-HBV/Hib Kft DTPw-HBV/Hib DTPw-HBV Kft

Eligibility Criteria

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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.

Minimum Eligible Age

10 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

City of Muntinlupa, , Philippines

Site Status

GSK Investigational Site

Pasay, , Philippines

Site Status

GSK Investigational Site

Quezon City, , Philippines

Site Status

Countries

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Philippines

References

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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

Reference Type BACKGROUND

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. doi: 10.4161/hv.4.1.5069. Epub 2007 Sep 23.

Reference Type BACKGROUND

PMID: 18376148 (View on PubMed)

Study Documents

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