Last updated: 11/03/2018 00:28:02
Immune response post pry vaccination of 2 formulations of DTPw-HBV vaccine given with rotavirus vaccine to infants
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A phase III, partially blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Tritanrix™-HepB and GSK Biologicals Kft’s DTPw-HBV vaccines as compared to concomitant administration of Commonwealth Serum Laboratory’s (CSL’s) DTPw (Triple Antigen™) and GSK Biologicals’ HBV (Engerix™-B), when co-administered with GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine, to healthy infants at 3, 4½ and 6 months of age, after a birth dose of hepatitis B vaccine.
Trial description: To compare the two formulations of GSK Biologicals’ DTPw-HBV vaccine to concomitant administration of CSL’s DTPw vaccine and GSK Biologicals’ HBV with respect to the antibody response to the diphtheria antigen after a three-dose primary vaccination course.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Seroprotection status for anti-diphteria (anti-DT) antibodies
Timeframe: At one month post dose 3 [PIII(M4)]
Secondary outcomes:
Number of seroprotected subjects for anti-DT antibodies as assessed by ELISA
Timeframe: At one month post dose 3 [PIII(M4)]
Number of seroprotected subjects for anti-Hepatitis B (anti-HBs) antibodies
Timeframe: At one most post dose 3 [PIII(M4)]
Number of seropositive subjects with Anti-Bordetella Pertussis (anti-BPT) antibody concentrations ≥ the established cut-off values
Timeframe: At one month post dose 3 [PIII(M4)]
Number of subjects with vaccine response to BPT antigen
Timeframe: At one month post dose 3 [PIII(M4)]
Number of seropositive subjects with anti-rotavirus (anti-RV) antibodies above the cut-off values
Timeframe: At 2.5 months after dose 2 of Rotarix [PIII(M4)]
Number of seroprotected subjects for anti-Tetanus (anti-T) antigen
Timeframe: At one month post dose 3 [PIII(M4)]
Number of seroprotected subjects for anti-Poliovirus types 1, 2, 3 (anti-Polio 1, 2, 3)
Timeframe: At one month post dose 3 [PIII(M4)]
Concentrations of anti-HBs antibodies
Timeframe: At one month post dose 3 [PIII(M4)]
Concentrations of anti-DT antibodies
Timeframe: At one month post dose 3 [PIII(M4)]
Concentrations of anti-T antibodies
Timeframe: At one month post dose 3 [PIII(M4)]
Concentrations of anti-BPT antibodies
Timeframe: At one month post dose 3 [PIII(M4)]
Concentrations of anti-RV antibodies
Timeframe: At 2.5 months post dose 2 of Rotarix [PIII(M4)]
Anti-Polio type 1, 2, 3 antibody titers
Timeframe: At one month post dose 3 [PIII(M4)]
Number of subjects with solicited local symptoms
Timeframe: During the 8-Day (Days 0-7) follow-up period
Number of subjects with any solicited general symptoms
Timeframe: During the 8-day period (Days 0-7) post-vaccination
Number of subjects with unsolicited adverse events (AEs)
Timeframe: During the 31-day (Days 0-30) follow-up period
Number of subjects with serious adverse events (SAEs)
Timeframe: From Month 0 to Month 4
Interventions:
Biological/vaccine: Tritanrix™-HepB
Biological/vaccine: Rotarix™
Biological/vaccine: Zilbrix™
Biological/vaccine: Triple Antigen™
Biological/vaccine: Engerix™-B
Drug: Placebo
Enrollment:
308
Observational study model:
Not applicable
Primary completion date:
2006-23-11
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hepatitis B
Product
GSK196131A
Collaborators
Not applicable
Study date(s)
September 2005 to November 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
3 weeks - 4 months
Accepts healthy volunteers
Yes
- Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol.
- Administration of one dose of hepatitis B vaccine at birth.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol.
- Administration of one dose of hepatitis B vaccine at birth.
- A male or female between, and including, 11 and 17 weeks of age at the time of the first DTPw vaccination.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Exclusion criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exception of oral polio vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required)
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Trial location(s)
Location
GSK Investigational Site
Ivanteevka Moscow region, Russia, 141280
Status
Terminated/Withdrawn
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2006-23-11
Actual study completion date
2006-23-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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