Study of a Birth Dose of GlaxoSmithKline Biologicals' 251154 Vaccine
This study has been withdrawn prior to enrollment.
(Study was cancelled before enrolment for reasons not related to vaccine safety or efficacy.)
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01110044
First received: April 22, 2010
Last updated: February 24, 2011
Last verified: February 2011
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Purpose
The purpose of the study is to evaluate the safety and immunogenicity of a birth dose of GSK Biologicals' reduced-antigen-content tri-component pertussis (251154) vaccine followed by routine paediatric vaccination.
| Condition | Intervention | Phase |
|---|---|---|
|
Poliomyelitis Haemophilus Influenzae Type b Disease Hepatitis B Diphtheria Pertussis Pneumococcal Diseases Tetanus |
Biological: 251154 vaccine Biological: Infanrix hexa™ Biological: Synflorix™ Biological: Rotarix™ |
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: | Immunogenicity and Safety of a Birth Dose of GlaxoSmithKline Biologicals' Reduced-antigen-content Tri-component Pertussis (251154) Vaccine |
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:
- Immunogenicity with respect to components of the study vaccines. [ Time Frame: One month after the first dose of primary vaccination. ] [ Designated as safety issue: No ]
- Immunogenicity with respect to components of the study vaccines. [ Time Frame: One month after the third dose of primary vaccination. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Immunogenicity with respect to components of the study vaccines (on secondary readouts). [ Time Frame: One month after the second dose of primary vaccination. ] [ Designated as safety issue: No ]
- Immunogenicity with respect to components of the study vaccines (on secondary readouts). [ Time Frame: One month after the third dose of primary vaccination. ] [ Designated as safety issue: No ]
- Immunogenicity with respect to components of the study vaccines (on secondary readouts). [ Time Frame: One month after booster vaccination. ] [ Designated as safety issue: No ]
- Occurrence of solicited local and general symptoms (on secondary readouts). [ Time Frame: On Day 0-Day 7 after neonatal vaccination. ] [ Designated as safety issue: No ]
- Occurrence of solicited local and general symptoms (on secondary readouts). [ Time Frame: On Day 0-Day 3 after each dose of primary and booster vaccination. ] [ Designated as safety issue: No ]
- Occurrence of unsolicited adverse events (on secondary readouts). [ Time Frame: On Day 0-Day 30 after each vaccination. ] [ Designated as safety issue: No ]
- Occurrence of serious adverse events (on secondary readouts). [ Time Frame: From enrolment up to study end. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 376 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group A
Subjects will be administered 251154 vaccine at birth, Infanrix hexa™ at 2, 4, 6 and 12-18 months of age, Synflorix™ at 2, 4, 6 and 12-18 months of age, Rotarix™ at 2 and 4 months of age.
|
Biological: 251154 vaccine
Intramuscular, single dose
Biological: Infanrix hexa™
Intramuscular, four doses
Biological: Synflorix™
Intramuscular, four doses
Biological: Rotarix™
Oral, two doses
|
|
Active Comparator: Group B
Subjects will be administered no vaccine at birth, Infanrix hexa™ at 2, 4, 6 and 12-18 months of age, Synflorix™ at 2, 4, 6 and 12-18 months of age, Rotarix™ at 2 and 4 months of age.
|
Biological: Infanrix hexa™
Intramuscular, four doses
Biological: Synflorix™
Intramuscular, four doses
Biological: Rotarix™
Oral, two doses
|
Eligibility| Ages Eligible for Study: | up to 5 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Subjects who the investigator believes that their parent(s)/LAR(s) can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- A male or female infant between, and including, 2 and 5 days of age at the time of randomisation.
- Subjects who are born after an uncomplicated gestation period of 36 to 42 weeks inclusive.
- Subjects born to a mother seronegative for hepatitis B surface antigen.
- Subjects with a birth weight >= 2.5 kg.
- Subjects with a 5-minute Apgar score >= 7.
- Healthy subjects as established by medical history and clinical examination
Exclusion Criteria:
- Use of any investigational or non-registered product other than the study vaccines since birth, or planned use during the study period.
- Born to a mother known or suspected to be seropositive for HIV.
- Family history of congenital or hereditary immunodeficiency.
- Children in care..
- Neonatal jaundice requiring systemic treatment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Administration of any vaccine since birth or planned administration during the study period with the exception of inactivated influenza vaccines.
- 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.
- History of seizures or progressive neurological disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- Major congenital defects or serious chronic illness, including perinatal brain damage.
The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:
• Current febrile illness or temperature >= 38.5°C on oral or axillary setting, or >= 39.0°C on rectal setting, or other moderate to severe illness within 24 hours of study vaccine administration.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT01110044 History of Changes |
| Other Study ID Numbers: | 112980 |
| Study First Received: | April 22, 2010 |
| Last Updated: | February 24, 2011 |
| Health Authority: | Belgium: Agence Fédérale des Médicaments et des Produits de la Santé Canada: Biologics and Genetic Therapies Directorate (BGTD) Germany: Paul-Ehrlich-Institut Sweden: Medical Products Agency Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by GlaxoSmithKline:
|
Neonatal 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 23, 2013