A Study to Evaluate the Safety and Immunogenecity of LBVE(Multivalent Pneumococcal Conjugate Vaccine) in Healthy Infants

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and immunogenicity of LBVE (Multivalent Pneumococcal Conjugate Vaccine) in healthy infants.

Official Title
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A Single-blind, Multi-center, Randomized, Active-controlled, Parallel Group, Phase II Study to Evaluate the Safety and Immunogenicity of Intramuscular Three Injections With LBVE(Multivalent Pneumococcal Conjugate Vaccine) Compared to Prevnar13 in Healthy Infants

Conditions
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Pneumococcal Infection

Intervention / Treatment
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* Biological: LBVE
* Biological: Prevnar13


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy infants of either sex who have reached at least 42 days (6 weeks) of age and not more than 56 days (8 weeks) of age at the time of enrollment. The parents or LAR(Legally authorized representative) able to understand and comply with planned study procedures. Signed informed consent by subject's parents or LAR(Legally authorized representative) Exclusion Criteria: Previously received any pneumococcal vaccine Receipt of immunoglobulin or blood-derived product before the study Known or suspected immune disorder, or received immunosuppressive therapy Known major congenital malformation or serious chronic disorder Participation in another interventional trial

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 8 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LBVE<br>Infants will receive a 0.5mL intramuscular injection of LBVE at 6,10 and 14 weeks of age | Biological: LBVE<br>* Multivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh<br>|
| Active Comparator: Prevnar13<br>Infants will receive a 0.5mL intramuscular injection of Prevnar13 at 6,10 and 14 weeks of age | Biological: Prevnar13<br>* 13-valent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects achieving pneumococcal serotype-specific IgG >= 0.35 ug/ml |  | 4 weeks after 3rd(last) vaccination | 
| Pneumococcal serotype-specific IgG geometic mean concentration (GMC) ratios |  | 4 weeks after 3rd(last) vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects achieving targeted pneumococcal serotype-specific opsonophagocytic assay (OPA) titer |  | 4 weeks after 3rd(last) vaccination | 
| Pneumococcal serotype-specific OPA geometic mean titer (GMT) ratios |  | 4 weeks after 3rd(last) vaccination | 
| Solicited adverse events |  | Baseline(pre-vaccination) up to 7 days after each vaccination | 
| Unsolicited adverse events |  | Baseline(pre-vaccination) up to 4 weeks after 3rd(last) vaccination |