Meningitis, Meningococcal, Rotavirus Infections
Conditions
Keywords
Prevention of Gastroenteritis due to rotavirus infection. And prevention of Invasive disease caused by Neisseria meningitidis serogroup C.
Brief summary
Primary objective: To check if RotaTeq® can be administered concomitantly with meningococcal Group C vaccine without impairing the efficacy of MCC vaccine. The hypothesis tested is that the seroprotection rate for MMC at 28 days after the second MCC vaccination with concomitant administration of RotaTeq® is non-inferior to that without non-concomitant (sequential) administration of RotaTeq®.
Interventions
BIOLOGICALRotaTeq®
Rotavirus vaccine, live, oral, pentavalent, 2 mL solution for oral administration.
BIOLOGICALNeisVac-C®
Meningiococcal Group C Polysaccharide Conjugate Vaccine Absorbed, 0.5 mL suspension for intramuscular injection.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
42 Days to 55 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy infants, aged from 6 weeks through full 7 weeks, * Consent form signed by at least one parent or by the legal representative properly informed about the study, * Parent(s) / legal representative able to understand the protocol requirements and to fill in the Diary Card.
Exclusion criteria
* History of congenital abdominal disorders, congenital malformation of the gastrointestinal tract that could predispose to intussusception, or abdominal surgery, * Congenital fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency, * Known or suspected impairment of immunological function, * Known hypersensitivity to any component of RotaTeq® (e.g. sucrose) or of NeisVac-C® (including tetanus toxoid), * Prior administration of any rotavirus vaccine, * Prior administration of any vaccine within the 28 days prior to randomisation, * Fever (rectal temperature ≥38.1°C) and/or acute diarrhoea and/or vomiting at randomisation, * History of known prior rotavirus gastroenteritis, chronic diarrhoea, or failure to thrive, * Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection, * Clinical evidence of active gastrointestinal illness, * Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 14 days prior to randomisation. Note: Infants on inhaled and/or topical steroids may participate in the study, * Infants residing in a household with an immunocompromised person, * Prior receipt of a blood transfusion or blood products, including immunoglobulins.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype | 28 days after the second dose of MCC vaccine (approximately 20 weeks) | Antibody seroprotection to meningiococcal Group C serotype was measured by serum bactericidal antibody with rabbit complement (sRBA). The criterion for seroresponse was an sRBA titer \>=1:8. |
Participant flow
Recruitment details
A total of 249 participants were screened and 247 were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Concomitant Administration Participants received 2 concomitant doses of RotaTeq® and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age and a third dose of RotaTeq® at 24-25 weeks of age (and 28 to 42 days after the vaccine administration at 20-21 weeks of age) | 124 |
| Group 2: Sequential Administration Participants received 3 doses of RotaTeq® at 6-7 weeks of age, 15-16 weeks of age, and 24-25 weeks of age (and 28 to 42 days after the MMC vaccine administered at 20-21 weeks of age), and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age. | 123 |
| Total | 247 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Not vaccinated, no blood sample drawn | 1 | 0 |
| Overall Study | Personal reason | 8 | 3 |
| Overall Study | Withdrawn due to intercurrent disease | 1 | 0 |
Baseline characteristics
| Characteristic | Group 1: Concomitant Administration | Group 2: Sequential Administration | Total |
|---|---|---|---|
| Age, Continuous | 7.1 Weeks STANDARD_DEVIATION 0.5 | 7.2 Weeks STANDARD_DEVIATION 0.6 | 7.1 Weeks STANDARD_DEVIATION 0.5 |
| Sex: Female, Male Female | 50 Participants | 55 Participants | 105 Participants |
| Sex: Female, Male Male | 74 Participants | 68 Participants | 142 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 98 / 116 | 105 / 122 |
| serious Total, serious adverse events | 1 / 116 | 1 / 122 |
Outcome results
Primary
Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype
Antibody seroprotection to meningiococcal Group C serotype was measured by serum bactericidal antibody with rabbit complement (sRBA). The criterion for seroresponse was an sRBA titer \>=1:8.
Time frame: 28 days after the second dose of MCC vaccine (approximately 20 weeks)
Population: The population analyzed was randomized participants excluding those with protocol violations that may have interfered with the immunogenicity evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Concomitant Administration | Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype | 100 Percentage of participants |
| Group 2: Sequential Administration | Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype | 100 Percentage of participants |
Comparison: Analysis of non-inferiority was based on the Miettinen and Nurminen method95% CI: [-3.7, 3.7]