Pneumonia
Conditions
Keywords
pneumococcal conjugate vaccine, immunogenicity, safety
Brief summary
In order to evaluate immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine produced by Beijing Minhai Biotechnology Co., Ltd., a randomized, double-blind, parallel-controlled phase III clinical trial is planned to conduct in healthy infants aged 2 months in China.
Detailed description
There will be two arms. 1200 healthy infants aged 2 months will be randomly assigned (1:1) to receive an experimental vaccine or a comparator vaccine in Month 0,2 and 4 (primary vaccination). All of them will receive a fourth dose as booster vaccination in Month 10.
Interventions
BIOLOGICALPrevnar 13
0.5ml vaccine produced by Wyeth,three doses with 2 month interval, a booster dose 10 months after the first dose
BIOLOGICAL13-valent pneumococcal conjugate vaccine
0.5ml vaccine produced by Beijing Minhai Biotechnology Co., Ltd.,three doses with 2 month interval, a booster dose 10 months after the first dose
Sponsors
Beijing Minhai Biotechnology Co., Ltd
Jiangsu Province Centers for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
42 Days to 77 Days
Healthy volunteers
Yes
Inclusion criteria
* Aged 42-77 days old on the day of inclusion * Subjects' legal guardians are able to understand and sign the informed consent * Subjects' legal guardians can and will comply with the requirements of the protocol * Subjects with temperature \<=37.0°C on axillary setting
Exclusion criteria
for First Vaccination: * Preterm infants or low birth weight infants * Any administration history of pneumococcal polysaccharide vaccine or pneumococcal conjugate vaccine * A medical history of culture-confirmed invasive disease caused by Streptococcus pneumonia * Subject who has allergic history or serious adverse reaction history after vaccination such as allergies, hives, difficulty in breathing, angioedema or abdominal pain * Subject with congenital malformation, developmental disorder, genetic defects or severe malnutrition * Subject with epilepsy, a history of seizures or convulsions, or a family history of mental illness * Known or suspected immune deficiency or immune suppression * Diagnosed coagulation abnormalities (such as clotting factor deficiency, coagulation disorders, platelet disorder) or significant bruising or blood clotting disorder * Had immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (not including allergic rhinitis corticosteroid spray treatment, acute uncomplicated dermatitis surfaces corticosteroid therapy) in the past 6 months * Any prior administration of blood products in last 3 months * Any prior administration of any attenuated live vaccine in last 14 days * Any prior administration of subunit or inactivated vaccines in last 7 days * Any acute infection or serious infection needing systemic antibiotics or antiviral treatment in last 7 days * Any fever with temperature \>=38.0°C on axillary setting in last 3 days * Any other factors judged by investigator, that may interfere subject's compliance with the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric mean concentration (GMC) of serotype-specific pneumococcal IgG antibody 30 days after primary vaccination | 30 days after primary vaccination | Geometric mean concentration (GMC) of serotype-specific pneumococcal IgG antibody 30 days after primary vaccination |
| Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 0.35 ug/mL 30 days after primary vaccination | 30 days after primary vaccination | Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 0.35 ug/mL 30 days after primary vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with serotype-specific geometric mean titer measured by OPA ≥1:8 30 days after primary vaccination | 30 days after primary vaccination | Proportion of subjects with serotype-specific geometric mean titer measured by OPA ≥1:8 30 days after primary vaccination |
| Geometric mean titer (GMT) of serotype-specific pneumococcal IgG antibody measured by OPA 30 days after primary vaccination | 30 days after primary vaccination | Geometric mean titer (GMT) of serotype-specific pneumococcal IgG antibody measured by OPA 30 days after primary vaccination |
| Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 0.35 ug/mL 30 days after booster vaccination | 30 days after booster vaccination | Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 0.35 ug/mL 30 days after booster vaccination |
| Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 1.0 ug/mL 30 days after booster vaccination | 30 days after booster vaccination | Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 1.0 ug/mL 30 days after booster vaccination |
| Geometric mean concentration (GMC) of serotype-specific pneumococcal IgG antibody 30 days after booster vaccination | 30 days after booster vaccination | Geometric mean concentration (GMC) of serotype-specific pneumococcal IgG antibody 30 days after booster vaccination |
| Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 1.0 ug/mL 30 days after primary vaccination | 30 days after primary vaccination | Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 1.0 ug/mL 30 days after primary vaccination |
| Geometric mean titer (GMT) of serotype-specific pneumococcal IgG antibody measured by OPA 30 days after booster vaccination | 30 days after booster vaccination | Geometric mean titer (GMT) of serotype-specific pneumococcal IgG antibody measured by OPA 30 days after booster vaccination |
| Incidence of adverse reactions (including systemic and local adverse reaction) 30 days after each dose of vaccination | 30 days after each dose of vaccination | Incidence of adverse reactions (including systemic and local adverse reaction) 30 days after each dose of vaccination |
| Incidence of severe adverse event (SAE) within 6 months after the first doseof vaccination | 6 months after the first doseof vaccination | Incidence of severe adverse event (SAE) within 6 months after the first doseof vaccination |
| Incidence of severe adverse event (SAE) 30 days after booster vaccination | 30 days after booster vaccination | Incidence of severe adverse event (SAE) 30 days after booster vaccination |
| Proportion of subjects with serotype-specific geometric mean titer measured by OPA ≥1:8 30 days after booster vaccination | 30 days after booster vaccination | Proportion of subjects with serotype-specific geometric mean titer measured by OPA ≥1:8 30 days after booster vaccination |
| Geometric mean fold increase (GMI) of serotype-specific pneumococcal IgG antibody 30 days after primary vaccination | 30 days after primary vaccination | Geometric mean fold increase (GMI) of serotype-specific pneumococcal IgG antibody 30 days after primary vaccination |
Countries
China
Outcome results
None listed