Immunogenicity and safety of acellular pertussis (whooping cough) vaccine at birth
Phase 2
- Conditions
- whooping cough (pertussis)Infection - Other infectious diseases
- Registration Number
- ACTRN12609000905268
- Lead Sponsor
- Peter McIntyre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
Healthy infants (by history and physical examination) at the time of first vaccine, born at 37 weeks gestation or greater whose parents give written informed consent.
Exclusion Criteria
1.Contraindications to vaccination as listed in the Immunisation Handbook 9th Edition
2.Infant of mother known to be a carrier of hepatitis B virus
3.Administration of immunoglobulins and any blood products preceding the first dose of study vaccine or planned administration during the study period.
4.Any confirmed or suspected immunosuppressive or immunodeficient condition, in parent or child
5.Major congenital defects or serious chronic illness
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy.<br>Immunoglobulin G (IgG) to pertussis toxin (PT), pertactin and filamentous hemagglutinin (FHA) will be measured by enzyme-linked immunosorbent assay (ELISA) in maternal and infant serum samples at GSK Biologicals, Belgium, using a well-standardised assay.[at 6 weeks, 10 weeks, 6 and 8 months of age Blood samples will be taken as follows: maternal blood at birth, infant blood at 6 weeks, 10 weeks, 6 and 8 months.]
- Secondary Outcome Measures
Name Time Method Safety<br>a 7 day diary card will be given to parents to record any reaction include: fever (axillary temperature > 38oC ), drowsiness (unusually sleepy or inactive), fussiness scored as normal, periodically more irritable than usual but with normal activity [mild], prolonged crying and refused to play [moderate], prolonged crying and unable to be comforted [severe], anorexia defined as unusually poor appetite, vomiting judged to be greater than a posset, redness and swelling at the vaccination site each measured in mm, pain scored as none, minor light reaction to touch [mild], crying or protesting to touch [moderate], or crying when the leg is moved [severe]).[7 day diary card. Parents will be asked to record reactions 3 & 6 hours after injection, at bedtime each evening for 7 evenings.]