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PneumoniaPhase 3NCT02494999

A Phase III Clinical Trial of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants

A Phase 3 study testing 13-valent pneumococcal conjugate vaccine and Prevnar 13 in people with Pneumonia, run by Jiangsu Province Centers for Disease Control and Prevention at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 42 to 77 daysHealthy volunteers can take part
Conditions the study is for
Pneumonia
What is being tested?
13-valent pneumococcal conjugate vaccine and Prevnar 13
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
4 sitesChina
Study dates
Jun 2016to Oct 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 42 to 77 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 24Show fewer
  • 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
  • Exclusion Criteria for Second/Third and Booster Vaccination:
  • If one of the following (1) to (3) adverse events (AE) occurs, further vaccination is prohibited, but other study steps can be continued according to the judgment of the investigators; If one of the following (4) to (5) adverse events occurs, the investigator shall determine whether to continue the following vaccination. In the event of one of the following adverse events (6) to (7), vaccination may be postponed within the time window specified in the protocol.
  • （1）The subjects have suffered from severe adverse events caused by the previous vaccination.
  • （2）The subjects suffered from severe allergic reactions or hypersensitivity after the previous vaccination.
  • （3）Known or suspected autoimmune diseases or immunodeficiency diseases，including HIV infection.
  • （4）The occurrence of acute or emerging chronic diseases at the time of vaccination.
  • （5）Other reactions (including severe pain, severe swelling, severe restriction of movement, persistent high fever, severe headache, or other systemic or local reactions) judged by the investigators.
  • （6）Acute illness (acute illness refers to moderate or severe illness with or without fever) at the time of vaccination.
  • （7）The axillary temperature >37.0℃ at the time of vaccination.

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Huaiyin District Center for Diseases Control and Prevention

    Huai'an, Jiangsu, 222300

  • Hongze District Center for Disease Control and Prevention

    Huai'an, Jiangsu

  • Lianshui County Center for Disease Control and Prevention

    Huai'an, Jiangsu

  • Guanyun County Center for Disease Control and Prevention

    Lianyungang, Jiangsu

Other trials in China

About this study

Official title: A Randomized, Double-blind, Parallel-Controlled Phase III Clinical Trial of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants

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.

Read the 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.

Conditions
Pneumonia
Being tested
13-valent pneumococcal conjugate vaccine, Prevnar 13
Keywords
pneumococcal conjugate vaccine, immunogenicity, safety
Medical subject headings
Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • Prevnar 13Biological

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

Study groups in NCT02494999
Study groupRoleWhat they receive
13-valent pneumococcal conjugate vaccineExperimentalSingle 0.5 ml dose will be given via intramuscular injection in Month 0,2,4 and 10
Receives: Biological: 13-valent pneumococcal conjugate vaccine
Prevnar 13Active comparatorSingle 0.5 ml dose will be given via intramuscular injection in Month 0,2,4 and 10
Receives: Biological: Prevnar 13

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 30 days after primary vaccination

  2. 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

    Measured: 30 days after primary vaccination

Secondary outcomes (12)

  1. Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 1.0 ug/mL 30 days after primary vaccination

    Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 1.0 ug/mL 30 days after primary vaccination

    Measured: 30 days after primary vaccination

  2. Geometric mean fold increase (GMI) of serotype-specific pneumococcal IgG antibody 30 days after primary vaccination

    Geometric mean fold increase (GMI) of serotype-specific pneumococcal IgG antibody 30 days after primary vaccination

    Measured: 30 days after primary vaccination

  3. Proportion of subjects with serotype-specific geometric mean titer measured by OPA ≥1:8 30 days after primary vaccination

    Proportion of subjects with serotype-specific geometric mean titer measured by OPA ≥1:8 30 days after primary vaccination

    Measured: 30 days after primary vaccination

  4. Geometric mean titer (GMT) of serotype-specific pneumococcal IgG antibody measured by OPA 30 days after primary vaccination

    Geometric mean titer (GMT) of serotype-specific pneumococcal IgG antibody measured by OPA 30 days after primary vaccination

    Measured: 30 days after primary vaccination

  5. 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 ≥ 0.35 ug/mL 30 days after booster vaccination

    Measured: 30 days after booster vaccination

  6. Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 1.0 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

    Measured: 30 days after booster vaccination

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

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

    Measured: 30 days after booster vaccination

  8. Proportion of subjects with serotype-specific geometric mean titer measured by OPA ≥1:8 30 days after booster vaccination

    Proportion of subjects with serotype-specific geometric mean titer measured by OPA ≥1:8 30 days after booster vaccination

    Measured: 30 days after booster vaccination

  9. Geometric mean titer (GMT) of serotype-specific pneumococcal IgG antibody measured by OPA 30 days after booster vaccination

    Geometric mean titer (GMT) of serotype-specific pneumococcal IgG antibody measured by OPA 30 days after booster vaccination

    Measured: 30 days after booster vaccination

  10. Incidence of adverse reactions (including systemic and local adverse reaction) 30 days after each dose of vaccination

    Incidence of adverse reactions (including systemic and local adverse reaction) 30 days after each dose of vaccination

    Measured: 30 days after each dose of vaccination

  11. Incidence of severe adverse event (SAE) within 6 months after the first doseof vaccination

    Incidence of severe adverse event (SAE) within 6 months after the first doseof vaccination

    Measured: 6 months after the first doseof vaccination

  12. Incidence of severe adverse event (SAE) 30 days after booster vaccination

    Incidence of severe adverse event (SAE) 30 days after booster vaccination

    Measured: 30 days after booster vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2015 (estimated)
  2. Study startJun 2016
  3. Primary completionDec 2018
  4. Study completionOct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02494999
Sponsor's protocol ID
JSVCT022
Status last verified
May 2020
First submitted
6 Jul 2015
Last updated
13 May 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 34706841

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 13-valent pneumococcal conjugate vaccine and Prevnar 13 in people with Pneumonia, run by Jiangsu Province Centers for Disease Control and Prevention at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 0.35 ug/mL 30 days after primary vaccination (time frame: 30 days after primary vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02494999, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020.

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