Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00170612
Status:
COMPLETED
Last Update Posted:
2008-10-21
First Post:
2005-09-13
Brief Title:
Pneumococcal Vaccination of Fiji Infants
Sponsor:
University of Melbourne
Organization:
University of Melbourne
Study Overview
Official Title:
A Single-Blind Open-Label Randomized Phase II Study of the Safety Immunogenicity and Impact on Pneumococcus Pnc Carriage of the Pnc Vaccination Regimens Combining 1 2 or 3 Doses of 7-Valent Pneumococcal Conjugate Vaccine PCV in the First 4 Months of Life Followed by a Single Dose of 23-Valent Pneumococcal Polysaccharide Vaccine PPS at 12 Months of Age
Status:
COMPLETED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pneumonia is the most common reason for admission of Fijian children to hospitals The most common germ causing pneumonia is streptococcus pneumoniae It is a common cause of meningitis infection around the brain and spinal cord ear infections and blood infections and it lives in the nose of humans A vaccine has been developed that will help prevent these common diseases but prevents only about one quarter of pneumonia cases and it is expensive This study explores new ways of giving this vaccine that are affordable safe and effective in countries such as Fiji About 550 Fijian infants presenting at 6 weeks of age for their first diptheria tetanus toxoid pertussis vaccine immunization to one of the participating Health Centers or Colonial War Memorial Hospital in urban Suva Fiji will be enrolled Children will remain in the study for 2 years Study procedures include full vaccination against 7 types of pneumococcus blood tests and nasal swabs
Detailed Description:
This research project began as a study of alternative strategies for Pnc Pneumococcus immunization for children in developing countries In the original study infants presenting to a health center in urban Fiji were randomized to receive 1 2 or 3 doses of PCV Prevnar followed by a dose of 23-valent PPS Pneumococcal polysaccharide vaccine at 6 or 9 months of age The regimens were compared with each other and with 2 control groups with respect to immunogenicity impact on carriage of vaccine type Pnc and response to a small dose of PPS at 15 months of age After the trial was underway and 228 infants had been recruited concerns were raised about the safety of PPS in infancy Specifically concerns were raised that it might result in later immunological hyporesponsiveness in some of the recipients to some of the serotypes After a thorough review it was decided to proceed with the study but to modify it so that it addressed directly the issue of potential hyporesponsiveness while not giving PPS to any children under 12 months of age This protocol represents the completion of the study with the new design for the children already enrolled and a new design for a further cohort of children who will be enrolled The newly designed trial will be a single blind open-label randomized controlled trial of 550 healthy infants Infants will be randomized to 1 of 8 equal groups to receive 0 1 2 or 3 doses of PCV Pneumococcal conjugate vaccine with or without a booster of PPS at 12 months of age Two control groups will be recruited 1 will receive no PCV in infancy and the other will receive a dose of PPS at 12 months of age At 18 months of age all infants will receive a 20 percent dose of PPS to stimulate and allow the assessment of immunological memory At 2 years of age any child who has received no or one dose of PCV Groups E F G and H will receive a single dose of PCV Blood samples will be taken at 18 weeks age 12 months of age before the 18 months dose and 4 weeks later In addition half of the children will have a blood sample taken at 9 months and the other half will have a sample taken 2 weeks after their 12 month dose of PPS The 9- and 12-month blood sample will assess the long-term persistence of circulating antibody and avidity maturation following a 1 2 or 3 dose primary series of PCV The primary objective is to demonstrate noninferiority at 19 months of age of those groups receiving PPS at 12 months and those who do not with respect to the proportion of children in each group with a satisfactory immune response at 19 months of age measured by OPA to each of the 11 serotypes included in the PPS for which an OPA has been developed The secondary objective is to assess the immunogenicity and impact on carriage of various Pnc vaccination regimens that combine 1 to 3 doses of PCV with a dose of PPS concerns regarding the potential for the development of hyporesponsiveness Endpoints to be evaluated will include serotype specific immunoglobulin G antibody measured by enzyme-linked immunosorbent assay to the 23 serotypes in the PPS avidity assays to the same serotypes opsonophagocytic assays to the 11 serotypes for which these assays are currently available and Pnc carriage by serotype With hyporesponsiveness as the primary endpoint of interest a scheme of analysis has been proposed which will require a minimum sample size of 500
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FNRERC Reference 2002-001 | None | None | None |