Haemophilus Influenzae Type b Clinical Trial
Official title:
Assessment of Long-term Antibody Persistence After a Booster Dose of GSK Biologicals' Hib & Meningococcal C Vaccine (Menitorix™) 811936 Given at 12-15 Months of Age to Subjects Primed With 3 Doses of Menitorix™ at 2, 3, 4 Months of Age
The purpose of this study is to evaluate the long-term antibody persistence at 12, 24 and 48
months after the administration of a booster dose of Menitorix™, given at 12-15 months of
age. The children had previously received 3 doses of Menitorix™ and Infanrix IPV™ or
Meningitec™ and Pediacel™ in infancy. In addition, the antibody persistence is to be
investigated in children of 40-43 months of age who received a 3-dose primary vaccination of
a MenC conjugate vaccine and a Hib containing vaccine in infancy without a booster dose of
MenC conjugate and Hib vaccine in the second year of life.
This protocol posting deals with objectives & outcome measures of the extension phases at 12,
24 and 48 months after the booster phase. The links to objectives and outcome measures of the
primary phase & booster phase at 12 to 15 months are provided below:
https://www.gsk-studyregister.com/study/2747 (Primary phase)
https://www.gsk-studyregister.com/study/2755 (Booster phase)
This multicentre & multicountry study is open and has 2 study groups at Visits 1 and 3
(HibMenC and LicMenC). An additional control group in the UK at the time of the second year
follow-up for persistence (subjects aged 40-43 months primed with MenC conjugate and Hib
vaccines in infancy with no subsequent booster dose, group NoBoost at Visit 2). These
subjects will receive a Hib catch-up vaccine at 40-43 months of age. The subjects of groups
HibMenC and LicMenC were randomized in the primary vaccination study 103974 and will not be
further randomized. The subjects of group NoBoost will not be randomized. All subjects at the
UK centre will receive Infanrix™-IPV at the second visit (i.e. 24 months after Menitorix
booster or at 40-43 months of age). In addition, the subjects of group NoBoost will receive a
Hib catch-up vaccine (Menitorix™) at the same visit.
Subjects of groups HibMenC and LicMenC will have 3 blood samples taken for immunogenicity
analyses: at 12, 24 & 48 months after the booster vaccination. Subjects of group NoBoost will
have 1 blood sample taken for immunogenicity analyses at 40-43 months of age. 75 new subjects
will be enrolled in this study (group NoBoost).
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00753649 -
Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants
|
Phase 4 | |
| Completed |
NCT01214889 -
Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine in South Korean Infants.
|
Phase 3 | |
| Completed |
NCT00534833 -
Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™
|
Phase 3 | |
| Completed |
NCT00379977 -
Study to Assess the Safety & Reactogenicity of GSK Biologicals' DTPa/Hib Vaccine When Given at 3, 4 and 5 Months of Age
|
Phase 3 | |
| Completed |
NCT00153556 -
Study to Eliminate Hib Carriage in Rural Alaska Native Villages
|
Phase 4 | |
| Completed |
NCT02853929 -
Evaluation of Immunogenicity and Safety of a Booster Dose of Infanrix Hexa™ in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery
|
Phase 4 | |
| Completed |
NCT02858440 -
A Study to Assess the Immunogenicity and Safety of GSK Biologicals' Infanrix-IPV/Hib Vaccine Administered as a Three-dose Vaccination Course at 3, 4.5 and 6 Months of Age and a Booster Dose at 18 Months of Age in Healthy Infants in Russia
|
Phase 3 | |
| Completed |
NCT01878435 -
Randomized Controlled Trial of the Impact of Mobile Phone Delivered Reminders and Travel Subsidies to Improve Childhood Immunization Coverage Rates and Timeliness in Western Kenya
|
N/A | |
| Completed |
NCT01983540 -
Antibody Persistence at Age 3.5 and 4.5 Years After Primary and Booster DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccination
|
Phase 3 | |
| Completed |
NCT00376779 -
Immunogenicity and Safety of a DTPa-HBV-IPV/Hib Vaccine Given at 2, 3 and 4 Months of Age
|
Phase 2 | |
| Completed |
NCT00401531 -
Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants
|
Phase 3 | |
| Completed |
NCT00831311 -
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants
|
Phase 2 | |
| Completed |
NCT01457547 -
Comparison of Immunogenicity and Reactogenicity of INFANRIX™ HEXA and HEXAVAC™ Vaccines as a Primary Vaccination Course
|
Phase 4 | |
| Completed |
NCT00254917 -
Assessment of the Immunogenicity and Safety of PENTAXIM™ in Philippines
|
Phase 4 | |
| Completed |
NCT01453998 -
Safety and Immunogenicity of a Booster Dose of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)
|
Phase 2 | |
| Completed |
NCT01449812 -
Immunogenicity and Safety Study of Booster Dose of GSK Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) Vaccine
|
Phase 3 | |
| Completed |
NCT00808392 -
Safety and Immunogenicity of a Monovalent Conjugated Vaccine Against Haemophilus Influenzae Type b
|
Phase 3 | |
| Completed |
NCT00307567 -
Multicentre Booster & Immune Memory Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine or a Single Dose of 23-valent Plain Polysaccharide Vaccine in Healthy Children Aged 11-18 Mths, Previously Vaccinated in Study 103488
|
Phase 2 | |
| Completed |
NCT00323050 -
Study of a Booster Dose of Hib-MenC Conjugate Vaccine vs Infanrix Hexa When Given to 14 Month Old Subjects
|
Phase 3 | |
| Completed |
NCT00325156 -
Assess the Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 & 18 Mths of Age, in Healthy Infants
|
Phase 4 |