Assess the Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 & 18 Mths of Age, in Healthy Infants
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00325156
First received: February 8, 2006
Last updated: November 8, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
To assess the safety and reactogenicity of the DTPa-IPV/Hib vaccine as primary and booster vaccination. The DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals' rotavirus vaccine or Placebo.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
| Condition | Intervention | Phase |
|---|---|---|
|
Diphtheria, Tetanus, Pertussis, Poliomyelitis & Haemophilus Influenzae Type b Disease Diphtheria-Tetanus-aPertussis-Poliomyelitis Vaccines |
Biological: GSK Biologicals' combined DTPa-IPV/Hib vaccine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | An Open, Multicentric, Post-marketing Surveillance Study to Assess the Safety and Reactogenicity of GlaxoSmithKline Biologicals' DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 and 18 Months of Age, in Healthy Infants. |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Occurrence of solicited local and general adverse events [ Time Frame: During the 4-day follow up period after vaccination ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Occurrence of unsolicited local and general adverse events [ Time Frame: During the 30-day follow up period after vaccination ] [ Designated as safety issue: Yes ]
- Occurrence of large swelling reactions [ Time Frame: After booster dose ] [ Designated as safety issue: Yes ]
- Occurrence of serious adverse events. [ Time Frame: During the entire study period ] [ Designated as safety issue: Yes ]
| Enrollment: | 2590 |
| Study Start Date: | November 2004 |
| Study Completion Date: | August 2007 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Group A |
Biological: GSK Biologicals' combined DTPa-IPV/Hib vaccine
4 intramuscular injections
Other Name: GSK Biologicals' combined DTPa-IPV/Hib vaccine
|
Detailed Description:
Single group study. Subjects in GSK Biologicals' rotavirus study (Rota-028) in Singapore will be enrolled in this study. 3-4-5 month schedule with a booster dose at 18 months
Eligibility| Ages Eligible for Study: | 11 Weeks to 17 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion criteria
- Subjects must have been enrolled in the Rota-028 study.
- A male or female between, and including, 11 and 17 weeks of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
Exclusion criteria
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of the vaccine and ending 30 days after.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Contacts and Locations More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00325156 History of Changes |
| Other Study ID Numbers: | 100917 |
| Study First Received: | February 8, 2006 |
| Last Updated: | November 8, 2012 |
| Health Authority: | Singapore: Health Sciences Authority |
Additional relevant MeSH terms:
|
Diphtheria Influenza, Human Whooping Cough Poliomyelitis Tetanus Tetany Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
Bordetella Infections Gram-Negative Bacterial Infections Infection Myelitis Central Nervous System Viral Diseases Enterovirus Infections Picornaviridae Infections Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Neuromuscular Diseases Clostridium Infections Neuromuscular Manifestations Neurologic Manifestations |
ClinicalTrials.gov processed this record on May 23, 2013