Immune Memory Foll Pry Vaccination With DTPw-HBV/Hib Vaccine Formulation; Immuno & Reacto of Booster Dose at 15-18 Mths
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00158808
First received: September 8, 2005
Last updated: February 10, 2011
Last verified: February 2011
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Purpose
To assess the anti-PRP antibody response one month after vaccination in the groups receiving a fourth consecutive dose of two formulations of DTPw-HBV/Hib vaccine
| Condition | Intervention | Phase |
|---|---|---|
|
Hib Disease Hepatitis B Pertussis Prophylaxis of Diphtheria Tetanus |
Biological: Diphteria, tetanus, whole-cell pertussis, hepatitis B & Hib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Assess the Immunogenicity &d Reactogenicity of a Booster Dose of a Formulation of GSK Biologicals' DTPw-HBV/Hib Vaccine at 15-18 Mths of Age in Infants Previously Primed With the Same Vaccine |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Anti-PRP antibody concentration one month after the booster dose (in groups boosted with the DTPw-HBV/Hib vaccine). [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Immunology [ Designated as safety issue: No ]
- At the time of the booster dose: concentrations of antibodies against all vaccine antigens (diphtheria, tetanus, pertussis, hepatitis B and Hib antigens) [ Designated as safety issue: No ]
- One month after the booster dose: concentrations of antibodies against all vaccine antigens (diphtheria, tetanus, pertussis, hepatitis B and Hib antigens) [ Designated as safety issue: No ]
- Reactogenicity and Safety [ Designated as safety issue: No ]
- Occurrence of solicited symptoms during the specific follow-up period after the booster dose. [ Designated as safety issue: No ]
- Occurrence of unsolicited symptoms during the specific follow-up period after the booster dose . [ Designated as safety issue: No ]
- Occurrence of serious adverse events (SAEs) during the entire study period." [ Designated as safety issue: No ]
| Enrollment: | 175 |
| Study Start Date: | January 2005 |
| Study Completion Date: | April 2005 |
| Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
All subjects were previously primed with one of the two formulations of the combined DTPw-HBV/Hib vaccine. At the age of 10 months, 50% of each group received a plain PRP challenge to assess the immune memory to PRP. In this booster study in the second year of life, all subjects who received DTPw-HBV/Hib and plain PRP will receive DTPw-HBV as a booster vaccination. All other subjects will receive as booster the same vaccine they received in the primary vaccination study.
Eligibility| Ages Eligible for Study: | 15 Months and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion criteria
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- A male or female of at least 15 months of age at the time of the booster vaccination, who had previously received 3-dose primary vaccination and, if applicable, plain-PRP vaccination.
- Free of obvious health problems as established by medical history and clinical examination before entering the study.
Exclusion criteria for enrolment
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after administration of study vaccines with the exception of oral polio vaccine (OPV).
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.
- Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B or Hib with the exception of plain PRP challenge.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
Contacts and Locations More Information
No publications provided by GlaxoSmithKline
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00158808 History of Changes |
| Other Study ID Numbers: | 101477 |
| Study First Received: | September 8, 2005 |
| Last Updated: | February 10, 2011 |
| Health Authority: | Philippines: Bureau of Food and Drugs |
Additional relevant MeSH terms:
|
Diphtheria Hepatitis Hepatitis A Hepatitis B Whooping Cough Tetanus Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Bordetella Infections Gram-Negative Bacterial Infections Respiratory Tract Infections Infection Respiratory Tract Diseases Clostridium Infections |
ClinicalTrials.gov processed this record on May 23, 2013