Clinical Trials Logo
  1. Home
  2. Meningococcal Infection
  3. NCT00359983

Long-Term Antibody Persistence at 1, 3 and 5 Years After a Fourth Dose of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to ActHIB

Meningococcal Infection Clinical Trial

Official title:
A Study to Evaluate the Long-term Antibody Persistence at 1, 3 & 5 Years After the Administration of a Fourth Dose of Hib-MenCY-TT Vaccine Compared to ActHIB in Subjects Boosted in a Previous Study.

Clinical Trial Summary

This study is evaluating antibody persistence at 1, 3 & 5 years post-fourth dose (i.e., at 2, 4 & 6 years of age, respectively) in subjects vaccinated in a previous study.

This protocol posting deals with objectives & outcome measures of the extension phase at years 1, 3 and 5. The objectives & outcome measures of the first four doses are presented in a separate protocol posting (NCT00129129).

This protocol posting has been amended in order to comply with the FDA Amendment Act of September 26, 2007.

Clinical Trial Description

In this long-term follow-up study, no new subjects will be recruited. All subjects participating in this long-term follow-up study should have already participated in a previous study. No vaccine will be administered during the persistence phase of the study.

This Protocol Posting has been updated following Protocol amendment 3, September 2009. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00359983
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 3
Start date September 2006
Completion date May 2011
View Details
See also
  Status Clinical Trial Phase
Completed NCT01543087 - Duration of hSBA Response After a Primary Series of Bivalent rLP2086 Followed by a Booster Dose Phase 3
Completed NCT01442675 - Study of a Single Dose of Menactra® Vaccine 4-6 Years After Prior Menactra Vaccine Phase 2
Recruiting NCT06128733 - Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents Phase 1/Phase 2
Completed NCT00715234 - Evaluation of Vaccination Reminder/Recall Systems for Adolescent Patients N/A
Completed NCT01359449 - Study of Two Doses of Menactra® or One Dose of Monovalent Meningococcal Group C Vaccine With Routine Immunizations Phase 3
Recruiting NCT04843111 - Observational, Passive Surveillance Program to Collect Information on Women and Their Offspring Exposed to MenQuadfi® During Pregnancy, in United States (US)
Completed NCT01890759 - Immunogenicity and Safety of Menactra® Vaccine in Subjects Aged 9 to 23 Months in India and in the Russian Federation Phase 3
Completed NCT01086969 - A Study of Meningococcal Vaccine, Menactra® in Healthy Subjects in India Phase 3
Completed NCT00700635 - Dose Comparison Study of Menactra® in US Children Phase 2
Completed NCT00310635 - Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 Months of Age Phase 4
Completed NCT01659996 - Study of Menactra® in Healthy Subjects at 9 Months and Concomitantly With Pentacel® at 15 to 18 Months of Age Phase 4
Completed NCT00345683 - Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 12 to 15 Months of Age. Phase 3
Completed NCT01340898 - Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine When Co-administered With Routine Vaccines in Healthy Infants and Toddlers Phase 3
Completed NCT00392808 - Immunogenicity of the Booster Dose of Two MenC Vaccines Phase 4
Completed NCT00258856 - Persistence of Antibodies in Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or Menomune® Phase 2
Completed NCT06228586 - Study on a MenACYW Conjugate Vaccine Administered as a Single Dose in Participants Aged 12 Months and Older in Vietnam Phase 3
Completed NCT00806195 - Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants Phase 3
Completed NCT00269477 - Persistence of Antibodies in Adolescents and Adults 15 to 23 Years Who Received One Dose of Menactra® or Menomune® Phase 2
Completed NCT00643916 - Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months of Age Phase 2
Completed NCT01049035 - A Study of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Infants and Toddlers Phase 2