Neisseria Meningitidis-Haemophilus Influenzae Type b Vaccine Clinical Trial
Official title:
A Single-blind, Randomized, Controlled, Multinational Study for the Evaluation of Safety of GlaxoSmithKline (GSK) Biologicals' Investigational Vaccination Regimen Compared to Monovalent Haemophilus Influenzae Type b (Hib) Control Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age.
The primary phase of this study is evaluating the safety of Hib-MenCY-TT vaccine compared to
a control group receiving licensed Hib conjugate vaccine, when each are co-administered with
Pediarix® to healthy infants at 2, 4, and 6 months of age.
This protocol posting deals with objectives & outcome measures of the primary phase of the
study. The objectives & outcome measures of the Booster phase are presented in a separate
protocol posting (NCT number = 00345683).
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
2007
| Status | Completed |
| Enrollment | 4432 |
| Est. completion date | March 2008 |
| Est. primary completion date | October 2007 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 6 Weeks to 12 Weeks |
| Eligibility |
Inclusion Criteria: - Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol. - A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination. - Written informed consent obtained from the parent or guardian of the subject. - Healthy subjects as established by medical history and clinical examination before entering into the study. - Born after 36 weeks gestation. - Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrolment. - Infants may have received a birth dose of Bacillus Calmette-Guérin (BCG) vaccine. Exclusion criteria: Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. - Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. - Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s). - Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine. - In country(ies) where Prevnar will be provided by GSK Biologicals, previous vaccination with Prevnar. - History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, and/or poliovirus disease. - Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. - History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including dry natural latex rubber. - Major congenital defects or serious chronic illness. - History of any neurologic disorders or seizures. - Acute disease at time of enrollment. - Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. - Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Mexico | GSK Investigational Site | Mexico city | |
| Mexico | GSK Investigational Site | Mexico, D.F. | |
| United States | GSK Investigational Site | Akron | Ohio |
| 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 | 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 | Clyde | North Carolina |
| United States | GSK Investigational Site | Deerfield | North Carolina |
| United States | GSK Investigational Site | Fayetteville | Arkansas |
| 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 | Hot Springs | Arkansas |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Jamaica Plain | Massachusetts |
| United States | GSK Investigational Site | Jonesboro | Arkansas |
| United States | GSK Investigational Site | Katy | Texas |
| United States | GSK Investigational Site | Kingsport | Tennessee |
| 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 | 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 | Oaklawn | Illinois |
| 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 | 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 | 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 | Sylva | North Carolina |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States, Mexico,
Bryant KA, Marshall GS. Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines. 2011 Jul;10(7):941-50. doi: 10.1586/erv.11.90. Review. — View Citation
Rinderknecht S, Bryant K, Nolan T, Pavia-Ruz N, Doniz CA, Weber MA, Cohen C, Aris E, Mesaros N, Miller JM. The safety profile of Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine (HibMenCY). Hum Vaccin Immunother. 2012 Mar;8(3):304-11. doi: 10.4161/hv.18752. Epub 2012 Feb 13. — View Citation
| 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 Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5) | No |
| Primary | Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. | From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5) | No |
| Primary | Number of Subjects Reporting Rash | Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae. | From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5) | No |
| Primary | Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) | From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5) | 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 Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) | No |
| Primary | Number of Subjects With New Onset of Chronic Illnesses (NOCIs) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) | No |
| Primary | Number of Subjects With Rash | Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) | No |
| Primary | Number of Subjects With Adverse Events Resulting in Emergency Room (ER) | From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00454987 -
Study of Long-term Antibody Persistence After a Booster Dose of Menitorix Vaccine
|
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 |