Sepsis Clinical Trial
— PCV1103Official title:
A Study of Safety and Immunogenicity of 10-valent and 13-valent Pneumococcal Conjugate Vaccines to Inform Policy Regarding Pneumococcal Vaccination of Papua New Guinean Children
The study aims to evaluate the safety and immunogenicity of the 10-valent and 13-valent pneumococcal conjugate vaccines when administered in an accelerated schedule in Papua New Guinean children, who experience early dense upper respiratory tract colonisation with a broad range of pneumococcal serotypes, and to compare antibody titres following a booster dose of polysaccharide vaccine at 9 months with those children who received no booster at the same age.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | November 2016 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A to 35 Days |
Eligibility |
Inclusion Criteria: - Health infants between 28 - 35 days old Exclusion Criteria: - Infants of women not intending to remain in the are for at least two years - Birth weigh < 2000 g (2kg) - Severe congenital abnormalities - Mother or child known to be HIV positive |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Papua New Guinea | Papua New Guinea Institute of Medical Research | Goroka | Eastern Highlands Province |
Lead Sponsor | Collaborator |
---|---|
Papua New Guinea Institute of Medical Research | The University of Western Australia |
Papua New Guinea,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of children with serotype-specific IgG concentration >= 0.35ug/ml at 4 and 9 months of age for 90% of PCV vaccine serotypes and proportion of children with OPA >=1:8 titres at 4, 10 and 24 months | IgG concentration to vaccine serotypes are >= 0.35ug/ml post-dose 3 at 4 and 9 months. Serotype-specific IgG concentration >=0.35ug/ml is protective level against invasive pneumococcal diseases. Opsonophagocytic titre of >=1:8 examined at 4, 10 and 24 months will inform on functional antibodies induced by vaccination. | 3 years | No |
Secondary | Compare antibody concentrations to pneumococcal and Haemophilus influenzae protein antigens. | Measure antibody titres to surface proteins of pneumococci and Hi including Hi protein D, the carrier protein in PCV10 (Synflorix). | 2 years | Yes |
Secondary | Determine carriage rates and bacterial load of pneumococci and H.influenzae | Proportion of carriage before and after vaccination will be measured using conventional culture methods. Bacterial load will be measured using PCR to determine impact of vaccines | 3 years | No |
Secondary | Determine rates of hospital admission for acute respiratory tract infections at 9 and 23 months | Admissions and morbidity for acute respiratory tract infections will be documented at 9 and 23 months. | 2 yrs | Yes |
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