NCT02494999

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2016

Typical duration for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 13, 2015

Completed
11 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

May 13, 2020

Status Verified

May 1, 2020

Enrollment Period

2.5 years

First QC Date

July 6, 2015

Last Update Submit

May 11, 2020

Conditions

Pneumonia

Keywords

pneumococcal conjugate vaccineimmunogenicitysafety

Outcome Measures

Primary Outcomes (2)

  • Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 0.35 ug/mL 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

  • Geometric mean concentration (GMC) of serotype-specific pneumococcal IgG antibody 30 days after primary vaccination

    Geometric mean concentration (GMC) of serotype-specific pneumococcal IgG antibody 30 days after primary vaccination

    30 days after primary vaccination

Secondary Outcomes (12)

  • Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 1.0 ug/mL 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

    30 days after primary vaccination

  • Proportion of subjects with serotype-specific geometric mean titer measured by OPA ≥1:8 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

    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

  • +7 more secondary outcomes

Study Arms (2)

13-valent pneumococcal conjugate vaccine

EXPERIMENTAL

Single 0.5 ml dose will be given via intramuscular injection in Month 0,2,4 and 10

Biological: 13-valent pneumococcal conjugate vaccine

Prevnar 13

ACTIVE COMPARATOR

Single 0.5 ml dose will be given via intramuscular injection in Month 0,2,4 and 10

Biological: Prevnar 13

Interventions

13-valent pneumococcal conjugate vaccineBIOLOGICAL

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

13-valent pneumococcal conjugate vaccine
Prevnar 13BIOLOGICAL

0.5ml vaccine produced by Wyeth,three doses with 2 month interval, a booster dose 10 months after the first dose

Prevnar 13

Eligibility Criteria

Age42 Days - 77 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Huaiyin District Center for Diseases Control and Prevention

Huai'an, Jiangsu, 222300, China

Location

Hongze District Center for Disease Control and Prevention

Huai'an, Jiangsu, China

Location

Lianshui County Center for Disease Control and Prevention

Huai'an, Jiangsu, China

Location

Guanyun County Center for Disease Control and Prevention

Lianyungang, Jiangsu, China

Location

Related Publications (1)

  • Liang Q, Li H, Chang X, Zhang H, Hao H, Ye Q, Li G. A phase 3 clinical trial of MINHAI PCV13 in Chinese children aged from 7 months to 5 years old. Vaccine. 2021 Nov 16;39(47):6947-6955. doi: 10.1016/j.vaccine.2021.09.047. Epub 2021 Oct 24.

    PMID: 34706841DERIVED

MeSH Terms

Conditions

Pneumonia

Interventions

13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Yuemei Hu

    Jiangsu Provincial Centre for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2015

First Posted

July 13, 2015

Study Start

June 1, 2016

Primary Completion

December 1, 2018

Study Completion

October 1, 2019

Last Updated

May 13, 2020

Record last verified: 2020-05

Locations

CN(4)