Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01457495
First received: October 13, 2011
Last updated: October 20, 2011
Last verified: October 2011
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Purpose
This study will assess the immunogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared to the separate administration of DTPa-HBV-IPV (Infanrix™ penta) and Hib (Hiberix™) vaccines administered at 3 and 5 months of age.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis B Diphtheria Haemophilus Influenzae Type b (Hib) Poliomyelitis Pertussis Tetanus |
Biological: DTPa-HBV-IPV/Hib (Infanrix-hexa™) Biological: DTPa-IPV/Hib (Infanrix-IPV/Hib™) Biological: HBV (Engerix™-B) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Study to Assess Immunogenicity and Reactogenicity of SB Biologicals' DTPa-HBV-IPV/Hib Vaccine Given as Three-dose Primary Vaccination Course Compared to DTPa-IPV/Hib and HBV Administered Concomitantly at Separate Sites |
Resource links provided by NLM:
MedlinePlus related topics:
Diphtheria
Flu
Hepatitis
Hepatitis A
Hepatitis B
Polio and Post-Polio Syndrome
Tetanus
Whooping Cough
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Number of subjects with antibody titers equal to or greater than cut-off value. [ Time Frame: One month after the 2nd dose of the primary vaccination course (month 3) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Immunogenicity with respect to components of the study vaccines in terms of number of seropositive subjects [ Time Frame: One month after the 2nd dose (Month 3), before and one month after the 3rd dose of the primary vaccination course (Months 8 and 9) ] [ Designated as safety issue: No ]
- Immunogenicity with respect to components of the study vaccines in terms of antibody titers [ Time Frame: One month after the 2nd dose (Month 3), before and one month after the 3rd dose of the primary vaccination course (Months 8 and 9) ] [ Designated as safety issue: No ]
- Immunogenicity with respect to components of the study vaccines in terms of number of subjects with a vaccine response [ Time Frame: One month after the 3rd dose of the primary vaccination course (Month 9) ] [ Designated as safety issue: No ]
- Occurrence of solicited local symptoms [ Time Frame: Within 4 days after each vaccination and overall ] [ Designated as safety issue: No ]
- Occurrence of solicited general symptoms [ Time Frame: Within 4 days after each vaccination and overall ] [ Designated as safety issue: No ]
- Occurrence of unsolicited symptoms [ Time Frame: Within 30 days after each vaccination, and overall ] [ Designated as safety issue: No ]
- Occurrence of serious AEs [ Time Frame: Throughout the entire study (approximately 9 months per subject) up to and including 30 days post-vaccination ] [ Designated as safety issue: No ]
| Enrollment: | 312 |
| Study Start Date: | September 1998 |
| Study Completion Date: | September 1999 |
| Primary Completion Date: | September 1999 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: DTPa 1 Group |
Biological: DTPa-HBV-IPV/Hib (Infanrix-hexa™)
3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8
|
| Active Comparator: DTPa 2 Group |
Biological: DTPa-IPV/Hib (Infanrix-IPV/Hib™)
3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8
Biological: HBV (Engerix™-B)
3 doses administered intramuscularly into the left thigh at study month 0, 2 and 8
|
Eligibility| Ages Eligible for Study: | 12 Weeks to 16 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- A male or female between 12 and 16 weeks of age at the time of the first vaccination.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Written informed consent obtained from the parents or guardians of the subject after they have been advised of the risks and benefits of the study in a language which they clearly understood, and before performance of any study procedure.
Exclusion Criteria:
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
- Administration of chronic immunosuppressants or immune-modifying drugs during the study period.
- Administration of a vaccine not foreseen by the study protocol during the period starting from one month before each dose and ending one month after each dose.
- Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib diseases.
- History of/or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- History of allergic disease or reaction likely to be exacerbated by any component of the vaccine, including allergic reactions to neomycin and polymyxin B.
- Major congenital defects or serious chronic illness.
- Progressive neurological disorders.
- Administration of immunoglobulins and/or any blood products since birth and during the study period.
- Acute febrile illness at the time of planned vaccination.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT01457495 History of Changes |
| Other Study ID Numbers: | 217744/031 |
| Study First Received: | October 13, 2011 |
| Last Updated: | October 20, 2011 |
| Health Authority: | Slovakia: State Institute for Drug Control |
Keywords provided by GlaxoSmithKline:
|
Infants combined vaccine DTPa-HBV-IPV/Hib DTPa-IPV/Hib |
safety Immunogenicity HBV |
Additional relevant MeSH terms:
|
Diphtheria Hepatitis Hepatitis A Hepatitis B Influenza, Human Whooping Cough Poliomyelitis 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 Orthomyxoviridae Infections Respiratory Tract Infections Respiratory Tract Diseases Bordetella Infections Gram-Negative Bacterial Infections Infection Myelitis Central Nervous System Viral Diseases Central Nervous System Infections |
ClinicalTrials.gov processed this record on May 16, 2013