Haemophilus Influenzae Type b, Neisseria Meningitidis
Conditions
Keywords
H. influenzae type B vaccine, Infants, Neisseria meningitidis, Vaccines, conjugate, Meningococcal vaccines, Prophylaxis, Comparative study, Safety, Humans
Brief 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.
Detailed 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)
Interventions
BIOLOGICALGSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014)
Booster dose by intramuscular injection
BIOLOGICALPedvaxHIB
Booster dose by intramuscular injection
BIOLOGICALPrevnar
Booster dose by intramuscular injection
BIOLOGICALM-M-R II
Single dose by subcutaneous injection
BIOLOGICALVarivax
Single dose by subcutaneous injection
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
12 Months to 15 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Serious Adverse Events (SAEs) | From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14) | 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. |
| Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs) | From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. |
| Number of Subjects Reporting Rash | From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14) | Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae |
| 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) | — |
| Number of Subjects With Serious Adverse Events (SAEs) | 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) | 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. |
| Number of Subjects With New Onset of Chronic Illnesses (NOCIs) | 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) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. |
| Number of Subjects With Rash | 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) | Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae |
| 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) | — |
Countries
Mexico, United States
Participant flow
Recruitment details
This summary presents results for the booster/fourth dose vaccination phase up to the end of the 6-month safety follow-up. Subjects received 3-vaccine doses in the study NCT00345579 and were followed up to, but excluding, the fourth dose vaccination. This study begins 10 months after the first vaccination in the primary phase.
Pre-assignment details
Of the 4021 subjects enrolled, 4020 received a booster vaccination and 3986 completed the booster phase (2985 in the Menhibrix Group and 1001 in the ActHIB Group)
Participants by arm
| Arm | Count |
|---|---|
| Menhibrix Group Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh. | 3,010 |
| ActHIB Group Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh. | 1,010 |
| Total | 4,020 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 19 | 7 |
| Overall Study | Other | 6 | 2 |
Baseline characteristics
| Characteristic | Menhibrix Group | ActHIB Group | Total |
|---|---|---|---|
| Age, Continuous | 12.1 Days STANDARD_DEVIATION 0.34 | 12.1 Days STANDARD_DEVIATION 0.33 | 12.1 Days STANDARD_DEVIATION 0.34 |
| Sex: Female, Male Female | 1450 Participants | 505 Participants | 1955 Participants |
| Sex: Female, Male Male | 1560 Participants | 505 Participants | 2065 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 3,010 | 0 / 1,010 |
| serious Total, serious adverse events | 72 / 3,010 | 18 / 1,010 |
Outcome results
Primary
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
Time frame: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
Population: The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menhibrix Group | Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | 29 Subjects |
| ActHIB Group | Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | 16 Subjects |
Primary
Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
Population: The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menhibrix Group | Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs) | 12 Subjects |
| ActHIB Group | Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs) | 6 Subjects |
Primary
Number of Subjects Reporting Rash
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae
Time frame: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
Population: The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menhibrix Group | Number of Subjects Reporting Rash | 123 Subjects |
| ActHIB Group | Number of Subjects Reporting Rash | 41 Subjects |
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.
Time frame: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
Population: The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menhibrix Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 12 Subjects |
| ActHIB Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 1 Subjects |
Primary
Number of Subjects With Adverse Events Resulting in Emergency Room (ER) Visits
Time frame: 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)
Population: The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menhibrix Group | Number of Subjects With Adverse Events Resulting in Emergency Room (ER) Visits | 129 Subjects |
| ActHIB Group | Number of Subjects With Adverse Events Resulting in Emergency Room (ER) Visits | 48 Subjects |
Primary
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: 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)
Population: The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menhibrix Group | Number of Subjects With New Onset of Chronic Illnesses (NOCIs) | 50 Subjects |
| ActHIB Group | Number of Subjects With New Onset of Chronic Illnesses (NOCIs) | 18 Subjects |
Primary
Number of Subjects With Rash
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae
Time frame: 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)
Population: The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menhibrix Group | Number of Subjects With Rash | 227 Subjects |
| ActHIB Group | Number of Subjects With Rash | 82 Subjects |
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.
Time frame: 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)
Population: The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Menhibrix Group | Number of Subjects With Serious Adverse Events (SAEs) | 72 Subjects |
| ActHIB Group | Number of Subjects With Serious Adverse Events (SAEs) | 18 Subjects |