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NCT00345683 Clinical Trial

Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 12 to 15 Months of Age.

Meningococcal Infection Clinical Trial

Official title:
Single-blind, Randomized, Controlled, Multinational Study for the Evaluation of Safety of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to Monovalent Hib Control Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00345683
Other study ID # 105988
Secondary ID
Status Completed
Phase Phase 3
First received June 26, 2006
Last updated November 21, 2012
Start date July 2007
Est. completion date November 2008

Study information
Verified date November 2012
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Mexico: Federal Commission for Protection Against Health RisksUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The booster phase of the study will evaluate the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine at 12 to 15 months of age.

This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00345579).

No new recruitment will take place during this booster phase of the study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Description:

Hib-MenCY-TT = GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine.

The study will be conducted in a single blind manner up to 30 days after administration of the booster dose; the extended safety follow-up after the booster dose will be conducted in an unblinded manner.

All subjects will receive Prevnar, M-M-R II and Varivax as study vaccines, preferencially co-administered with the booster dose of Hib-MenCY-TT/PedvaxHIB.

Note: This protocol posting deals with the objectives & outcome measures for the booster phase of the study. The objectives & outcome measures for the primary phase are presented in a separate protocol posting (NCT00345579)

Recruitment information / eligibility
Status Completed
Enrollment 4021
Est. completion date November 2008
Est. primary completion date November 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Months to 15 Months
Eligibility Inclusion Criteria:

- Subjects enrolled in the primary study (NCT00345579) are eligible for participating in the booster study

Exclusion Criteria:

Subjects should not be administered M-M-R II and Varivax if any of these criteria apply:

- History of measles, mumps, rubella or varicella.

- Previous vaccination against measles, mumps, rubella or varicella.

- Hypersensitivity to any component of the vaccines, including gelatin or neomycin.

- Patients receiving immunosuppressive therapy.

- Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.

- Individuals with primary and acquired immunodeficiency states.

- Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.

- Individuals with active tuberculosis.

- Acute disease at time of booster vaccination

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014)
Booster dose by intramuscular injection
• PedvaxHIB
Booster dose by intramuscular injection
• Prevnar
Booster dose by intramuscular injection
• M-M-R II
Single dose by subcutaneous injection
• Varivax
Single dose by subcutaneous injection

Locations
Country Name City State
Mexico GSK Investigational Site Mexico city
Mexico GSK Investigational Site Mexico, D.F.
United States GSK Investigational Site Bardstown Kentucky
United States GSK Investigational Site Benton Arkansas
United States GSK Investigational Site Birmingham Alabama
United States GSK Investigational Site Birmingham Alabama
United States GSK Investigational Site Boardman Ohio
United States GSK Investigational Site Bossier City Louisiana
United States GSK Investigational Site Boston Massachusetts
United States GSK Investigational Site Boulder Colorado
United States GSK Investigational Site Canton Ohio
United States GSK Investigational Site Charleston South Carolina
United States GSK Investigational Site Cleveland Ohio
United States GSK Investigational Site Erie Pennsylvania
United States GSK Investigational Site Fountain Valley California
United States GSK Investigational Site Fresno California
United States GSK Investigational Site Fresno California
United States GSK Investigational Site Greenville Pennsylvania
United States GSK Investigational Site Ithaca New York
United States GSK Investigational Site Jonesboro Arkansas
United States GSK Investigational Site Kingsport Tennessee
United States GSK Investigational Site Las Vegas Nevada
United States GSK Investigational Site Layton Utah
United States GSK Investigational Site Lexington Kentucky
United States GSK Investigational Site Little Rock Arkansas
United States GSK Investigational Site Longmont Colorado
United States GSK Investigational Site Madera California
United States GSK Investigational Site Madison Wisconsin
United States GSK Investigational Site Marshfield Wisconsin
United States GSK Investigational Site Nampa Idaho
United States GSK Investigational Site New Hartford New York
United States GSK Investigational Site Nies Michigan
United States GSK Investigational Site North Canton Ohio
United States GSK Investigational Site Ogden Utah
United States GSK Investigational Site Orem Utah
United States GSK Investigational Site Pittsburgh Pennsylvania
United States GSK Investigational Site Pittsburgh Pennsylvania
United States GSK Investigational Site Pittsburgh Pennsylvania
United States GSK Investigational Site Pittsburgh Pennsylvania
United States GSK Investigational Site Pittsburgh Pennsylvania
United States GSK Investigational Site Plantation Florida
United States GSK Investigational Site Pleasant Gorve Utah
United States GSK Investigational Site Portage Michigan
United States GSK Investigational Site Raleigh North Carolina
United States GSK Investigational Site Salt Lake City Utah
United States GSK Investigational Site Salt Lake City Utah
United States GSK Investigational Site Slinas California
United States GSK Investigational Site South Euclid Ohio
United States GSK Investigational Site South Jordan Utah
United States GSK Investigational Site St. Paul Minnesota
United States GSK Investigational Site Stevensville Michigan
United States GSK Investigational Site Syracuse New York
United States GSK Investigational Site Waukee Iowa
United States GSK Investigational Site West Covina California
United States GSK Investigational Site West Desmoines Iowa
United States GSK Investigational Site West Jordan Utah
United States GSK Investigational Site Wexford Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Subjects Reporting Serious Adverse Events (SAEs) SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14) No
Primary Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs) NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14) No
Primary Number of Subjects Reporting Rash Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14) No
Primary Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14) No
Primary Number of Subjects With Serious Adverse Events (SAEs) SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) No
Primary Number of Subjects With New Onset of Chronic Illnesses (NOCIs) NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) No
Primary Number of Subjects With Rash Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) No
Primary Number of Subjects With Adverse Events Resulting in Emergency Room (ER) Visits From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19) No
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
Completed 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 Phase 3
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 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

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