Poliomyelitis
Conditions
Keywords
immunization, vaccine schedule, poliomyelitis, polio, oral polio vaccine, inactivated polio vaccine
Brief summary
Type 2 component of oral poliovirus vaccine is slated for global withdrawal through a switch from trivalent oral poliovirus vaccine (tOPV) to bivalent oral poliovirus vaccine (bOPV) for preventing paralytic polio caused by circulating vaccine-derived poliovirus type 2. We aimed to assess immunogenicity and safety profile of six vaccination schedules with different sequential doses of inactivated poliovirus vaccine (IPV), tOPV, or bOPV.
Detailed description
A randomized controlled trial was conducted in China in 2015. After informed consent was obtained from a parent or legally acceptable representative, healthy newborn babies were randomly allocated to one of six groups: cIPV-bOPV-bOPV, cIPV-tOPV-tOPV, cIPV-cIPV-bOPV, cIPV-cIPV-tOPV, cIPV-cIPV-cIPV, and tOPV-tOPV-tOPV. The key eligibility criteria were: full-term birth (37-42 weeks of gestation), birthweight ≥2·5 kg, no obvious medical disorders and no polio vaccination. Infants received following three doses sequentially with 4- 6 weeks interval after collecting blood sample: cIPV-bOPV-bOPV, cIPV-tOPV-tOPV, cIPV-cIPV-bOPV, cIPV-cIPV-tOPV, cIPV-cIPV-cIPV, and tOPV-tOPV-tOPV; and will be proactively followed up for observing adverse events after the first dose and 30 days after all doses. Antibodies of type 1, 2, and 3 poliovirus were tested 30 days after the third dose. The primary study objective was to investigate immunogenicity and safety profile of different vaccine schedules, evaluated by seroconversion, seroprotection and antibody titre against poliovirus types 1, 2, and 3 in the per-protocol population.
Interventions
BIOLOGICALpoliovirus vaccine
Different vaccination schedules with bOPV, tOPV and cIPV would be provided for 6 arms respectively.
Sponsors
Air Force Military Medical University, China
Beijing Tiantan Biological Products Co., Ltd.
Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Days to 90 Days
Healthy volunteers
Yes
Inclusion criteria
* Eligible participants were healthy full-term (37-42 weeks) infants aged 60-90 days who weighed more than 2·5 kg at birth with no obvious medical disorders, no polio vaccination, no immunoglobulin vaccinated, no other attenuated vaccine immured in the past 14 days and no other inactivated vaccine immured.
Exclusion criteria
* Participants were excluded if meet one or more of following criteria: were or were at risk of immunodeficiency, severe allergic reaction, acute fever and infectious diseases, severe chronic diseases, family history of allergies, convulsions, seizures, encephalopathy and psychiatric diseases, oral steroids at least 14 consecutive days in the past month, axillary temperature equal or greater than 38·0°C in the past three days, diarrhea (defection frequency equal or greater than three times per day) in the past seven days, and participated in other drug clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of infants with seroconversion | 30 days after vaccination | Primary immunogenicity outcome was the proportion of infants with seroconversion, which was defined as the 30 days post-vaccination titer equal or greater than eight for susceptible infants and the post-vaccination titer is four times higher than pre-vaccination titer for unsusceptible infants. Here, susceptible infants are the ones whose pre-vaccination titer less than eight. Otherwise, the subjects are categories as unsusceptible ones. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall seroprotection rate | 30 days after vaccination | Overall seroprotection rate was defined as the proportion of subjects with reciprocal titre of at least eight. |
| Geometric mean of antibody titres (GMT) | 30 days after vaccination | — |
| Increase of geometric mean of antibody titres (GMI) | 30 days after vaccination | — |
| Proportion of infants with serious adverse events | Six months after vaccination | — |
| Solicited adverse events | 30 days after vaccination | Solicited adverse events involving both systemic reactions (including fever, irritability/fussiness, somnolence, vomit, diarrhea, and allergic reaction) and local reactions (including tenderness, redness, swelling, and callous around the injection sites). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Proportion of infants with seroconversion in susceptible population | 30 days after vaccination | Proportion of infants with seroconversion, which was defined as the 30 days post-vaccination titer equal or greater than eight for susceptible infants. Here, susceptible infants are the ones whose pre-vaccination titer less than eight. |
| Proportion of infants with seroconversion in unsusceptible population | 30 days after vaccination | Proportion of infants with seroconversion, which was defined as the 30 days post-vaccination titer is four times higher than pre-vaccination titer for unsusceptible infants. |
Outcome results
None listed