Clinical trial NCT00169442: Immune Memory of DTPw-HBV/Hib Vaccine Following Primary Vaccination, Immuno & Reacto of a Booster Dose Given in Infants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Whole Cell Pertussis
Diphtheria
Hepatitis B
Tetanus
Haemophilus Influenzae Type b
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 745
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL
timeFrame: At Month 1, post-PRP challenge
measure: Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL.
timeFrame: At Month 1, post-booster vaccination
measure: Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)
timeFrame: At Month 1, post-booster vaccination
measure: Seroprotection Rates for Anti-D Antibodies
timeFrame: At Month 1, post-booster vaccination
measure: Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
timeFrame: At Month 1, post-booster vaccination
measure: Number of Seroprotected Subjects Against Bordetella Pertussis (BPT)
timeFrame: At Month 1, post-booster vaccination
measure: Number of Subjects With Booster Response to BPT Antigen
timeFrame: At Month 1, post-booster vaccination
measure: Anti-PRP Antibody Concentrations
timeFrame: At Month 1, post-PRP challenge
measure: Anti-PRP Antibody Concentrations.
timeFrame: At Month 1, post-booster vaccination
measure: Anti-D and Anti-T Antibody Concentrations
timeFrame: At Month 1, post-booster vaccination
measure: Anti-HBs Antibody Concentrations
timeFrame: At Month 1, post-booster vaccination
measure: Anti-BPT Antibody Concentrations
timeFrame: At Month 1, post-booster vaccination
Secondary outcomes:
measure: Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL
timeFrame: At Month 0, prior to the PRP challenge
measure: Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL.
timeFrame: At Month 0, prior to the PRP challenge
measure: Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value
timeFrame: At Month 0, prior to the PRP challenge
measure: Seroprotection Rates for Anti-D Antibodies
timeFrame: At Month 0, prior to the PRP challenge
measure: Number of Subjects With Anti-HBs Antibody Concentrations ≥ the Cut-off Value
timeFrame: At Month 0, prior to the PRP challenge
measure: Number of Subjects With Anti-BPT Antibody Concentrations ≥ the Cut-off Value
timeFrame: At Month 0, prior to the PRP challenge
measure: Anti- PRP Antibody Concentrations
timeFrame: At Month 0, prior to the PRP challenge
measure: Anti- PRP Antibody Concentrations.
timeFrame: At Month 0, prior to the PRP challenge
measure: Anti-D and Anti-T Antibody Concentrations.
timeFrame: At Month 0, prior to the PRP challenge
measure: Anti-HBs Antibody Concentrations.
timeFrame: At Month 0, prior to the PRP challenge
measure: Anti-BPT Antibody Concentrations.
timeFrame: At Month 0, prior to the PRP challenge
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 4-Day (Days 0-3) post-PRP challenge
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 4-Day (Days 0-3) post-PRP challenge
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
timeFrame: During the 4-Day (Days 0-3) post-booster vaccination period
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
timeFrame: During the 4-Day (Days 0-3) post-booster vaccination period
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: During the 31-Day (Day 0-30) follow-up period
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the entire study period (from Month 0 to Month 9.5)
Other outcomes:
Locations:
city: Muntinlupa
country: Philippines
facility: GSK Investigational Site
city: Pasay City
country: Philippines
facility: GSK Investigational Site
city: Quezon CIty
country: Philippines
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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
citation: 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.