Safety and Immunogenicity of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01248884
First received: November 24, 2010
Last updated: May 2, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
This study is designed to evaluate the safety and immunogenicity of new formulations of GSK Biologicals' DTPa-HBV-IPV/Hib vaccine (GSK217744) when administered as a primary vaccination course to healthy infants at 2, 3 and 4 months of age.
| Condition | Intervention | Phase |
|---|---|---|
|
Poliomyelitis Haemophilus Influenzae Type b Disease Hepatitis B Diphtheria Pertussis Tetanus |
Biological: GSK217744 Biological: Infanrix hexa™ Biological: Prevenar 13® |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Safety and Immunogenicity of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744) in Primary Infant Vaccination |
Resource links provided by NLM:
MedlinePlus related topics:
Diphtheria
Flu
Hepatitis
Hepatitis A
Hepatitis B
Polio and Post-Polio Syndrome
Tetanus
Whooping Cough
Drug Information available for:
Boostrix
Heptavalent pneumococcal conjugate vaccine
Adacel
Pneumococcal Vaccines
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Immunogenicity with respect to the components of the study vaccines [ Time Frame: One month after the third dose of primary vaccination (Month 3) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Immunogenicity with respect to the components of the study vaccines [ Time Frame: Before the first dose of primary vaccination (Day 0) and one month after the third dose of primary vaccination (Month 3) ] [ Designated as safety issue: No ]
- Occurrence of solicited local and general adverse events [ Time Frame: During the 8-day (Day 0-7) follow-up period after each vaccination ] [ Designated as safety issue: No ]
- Occurrence of unsolicited adverse events [ Time Frame: During the 31-day (Day 0-30) follow-up period after each vaccination ] [ Designated as safety issue: No ]
- Occurrence of serious adverse events [ Time Frame: From Day 0 to study end (Month 3) ] [ Designated as safety issue: No ]
| Enrollment: | 718 |
| Study Start Date: | December 2010 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group A
Subjects will receive GSK217744 Formulation A vaccine and Prevenar 13® at 2, 3 and 4 months of age.
|
Biological: GSK217744
Intramuscular, three doses
Biological: Prevenar 13®
Intramuscular, three doses
|
|
Experimental: Group B
Subjects will receive GSK217744 Formulation B vaccine and Prevenar 13® at 2, 3 and 4 months of age.
|
Biological: GSK217744
Intramuscular, three doses
Biological: Prevenar 13®
Intramuscular, three doses
|
|
Active Comparator: Group C
Subjects will receive Infanrix hexa™ and Prevenar 13® at 2, 3 and 4 months of age.
|
Biological: Infanrix hexa™
Intramuscular, three doses
Biological: Prevenar 13®
Intramuscular, three doses
|
Detailed Description:
This Protocol Posting has been updated following Protocol Amendment 1, February 2011, leading to the update of the exclusion criteria.
Eligibility| Ages Eligible for Study: | 60 Days to 90 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- A male or female between, and including, 60 and 90 days of age at the time of the first vaccination.
- Born after a gestation period of 37 to 42 weeks inclusive.
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
- Child in care.
- Use of any investigational or non-registered product other than the study vaccines 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.
- Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period, with the exception of oral rotavirus vaccination which is allowed at any time during the study.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, Hib and/or pneumococcal vaccination or disease, with the exception of hepatitis B vaccination at birth.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Family history of congenital or hereditary immunodeficiency.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- Major congenital defects or serious chronic illness.
- History of any neurological disorders or seizures.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Acute disease and/or fever at the time of enrolment.
Contacts and Locations More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01248884 History of Changes |
| Other Study ID Numbers: | 113948 |
| Study First Received: | November 24, 2010 |
| Last Updated: | May 2, 2013 |
| Health Authority: | United States: Food and Drug Administration Finland: FIMEA (Finnish Medicines Agency) |
Keywords provided by GlaxoSmithKline:
|
combination vaccine Primary vaccination |
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 22, 2013