Pneumococcal InfectionPhase 3NCT01692886
A Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Infants In China
A Phase 3 study testing 7-valent Pneumococcal Conjugate Vaccine and 13-valent Pnumococcal Conjugate vaccine in people with Pneumococcal Infection, run by Pfizer at 4 sites in China.
Trial summary
This study is primarily designed to evaluate the IgG immune responses to the 13 pneumococcal serotypes induced by 13vPnC compared with the immune responses induced by 7vPnC when measured 1 month after the infant series, and to evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence… Read more about this study
- Who is it for?
- Ages 42 to 77 daysHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infection
- What is being tested?
- 7-valent Pneumococcal Conjugate Vaccine and 13-valent Pnumococcal Conjugate vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,674 participants
- Where
- 4 sitesChina
- Study dates
- Sep 2012to Apr 2014
- 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 to 77 days (approximately 2 months) at the time of enrollment.
- Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
Who cannot join
- Previous vaccination with licensed or investigational pneumococcal vaccine.
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination with pneumococcal vaccines.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Jiangsu Province Guanyun County Center for Disease prevention and Control
Guanyun County,, Jiangsu, 222200
Jiangsu Province Hongze County Center for Disease prevention and Control
Huaian City, Jiangsu, 223100
Jiangsu Province Huaiyin District Center for Disease prevention and Control
Huaian City,, Jiangsu, 223300
Jiangsu Province Lianshui County Center for Disease prevention and Control
Lianshui County, Jiangsu, 223400
About this study
Official title: A Phase 3, Randomized, Active-controlled, Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13vpnc Compared With A 7vpnc In Healthy Infants In China
This study is primarily designed to evaluate the IgG immune responses to the 13 pneumococcal serotypes induced by 13vPnC compared with the immune responses induced by 7vPnC when measured 1 month after the infant series, and to evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local reactions, systemic events and adverse events.
- Conditions
- Pneumococcal Infection
- Being tested
- 7-valent Pneumococcal Conjugate Vaccine, 13-valent Pnumococcal Conjugate vaccine
- Keywords
- 13vPnC, 7vPnC, Healthy subjects, China
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7-valent Pneumococcal Conjugate VaccineBiological
Also called 7vPnC
suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 4-Month Visit, 5-Month Visit, and 12-Month Visit, respectively
13-valent Pnumococcal Conjugate vaccineBiological
Also called 13vPnC
suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 4-Month Visit, 5-Month Visit, and 12-Month Visit, respectively
13-valent Pnumococcal Conjugate vaccineBiological
Also called 13vPnC
suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 2-Month Visit, 4-Month Visit, 6-Month Visit, and 12-Month Visit, respectively
13-valent Pnumococcal Conjugate vaccineBiological
Also called 13vPnC
suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 5-Month Visit, and 12-Month Visit, respectively
| Study group | Role | What they receive |
|---|---|---|
| 7vPnC (3-, 4-, 5-, 12-Month) | Active comparator | Not described Receives: Biological: 7-valent Pneumococcal Conjugate Vaccine |
| 13vPnC (3-, 4-, 5-, 12-Month) | Experimental | Not described Receives: Biological: 13-valent Pnumococcal Conjugate vaccine |
| 13vPnC (2-, 4-, 6-, 12-Month) | Experimental | Not described Receives: Biological: 13-valent Pnumococcal Conjugate vaccine |
| 13vPnC (3-, 5-, 12-Month) | Experimental | Not described Receives: Biological: 13-valent Pnumococcal Conjugate vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 1 And Group 2.
Measured: 1 month after the infant series (6 Months of age)
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 3.
Measured: 1 month after the infant series (7 Months of age)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 1 and Group 2.
Measured: 1 month after the infant series (6 Months of age)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 3.
Measured: 1 month after the infant series (7 Months of age)
Percentage of Participants Reporting Adverse Events in Group 1 and Group 2.
Measured: Approximately 16 months from the participation into the study to the end of study
Percentage of Participants Reporting Adverse Events in Group 3 and Group 4.
Measured: Approximately 16 months from the participation into study to the end of study
Percentage of Participants Reporting Pre-Specified Local Reactions In the 7 Days After Each Pneumococcal Vaccination in Group 1 and Group 2.
Measured: Seven days after each pneumococcal vaccination dose within the period up to 12 months
Percentage of Participants Reporting Pre-Specified Local Reactions In the 7 Days After Each Pneumococcal Vaccination in Group 3 and Group 4.
Measured: Seven days after each pneumococcal vaccination dose within the period up to 12 months
Percentage of Participants Reporting Pre-Specified Systemic Events (Including The Use Of Antipyretic Medication) In the 7 Days After Each Pneumococcal Vaccination in Group 1 and Group 2.
Measured: Seven days after each pneumococcal vaccination dose within the period up to 12 months
Percentage of Participants Reporting Pre-Specified Systemic Events (Including The Use Of Antipyretic Medication) In the 7 Days After Each Pneumococcal Vaccination in Group 3 and Group 4.
Measured: Seven days after each pneumococcal vaccination dose within the period up to 12 months
Secondary outcomes (14)
Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 1 And Group 2.
Measured: 1 month after the infant series (6 Months of age)
Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 3.
Measured: 1 month after the infant series (7 Months of age)
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 1 and Group 2.
Measured: 1 month after the infant series (6 Months of age)
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 3.
Measured: 1 month after the infant series (7 Months of age)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose in Group 2 and Group 3.
Measured: 1 month after the toddler dose (13 Months of age)
Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Toddler Dose in Group 2 and Group 3.
Measured: 1 month after the toddler dose (13 Months of age)
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Toddler Dose in Group 2 and Group 3.
Measured: 1 month after the toddler dose (13 Months of age)
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 4.
Measured: 1 month after the infant series (6 Months of age)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 4.
Measured: 1 month after the infant series (6 Months of age)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose in Group 4.
Measured: 1 month after the toddler dose (13 Months of age)
Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 4.
Measured: 1 month after the infant series (6 Months of age)
Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Toddler Dose in Group 4.
Measured: 1 month after the toddler dose (13 Months of age)
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 4.
Measured: 1 month after the infant series (6 Months of age)
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Toddler Dose in Group 4.
Measured: 1 month after the toddler dose (13 Months of age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pneumococcal InfectionStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,674 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692886
- Sponsor's protocol ID
- B1851015
- Other IDs
- 6096A1-3019, 2009-017123-26, 2014-004953-14, 2014, 2009
- Status last verified
- Oct 2015
- First submitted
- 11 Jul 2012
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhu F, Hu Y, Li J, Ye Q, Young MM Jr, Liang JZ, Gruber WC, Giardina PC, Scott DA. Immunogenicity and Safety of the 13-Valent Pneumococcal Conjugate Vaccine Administered in a 3 + 1 versus 2 + 1 Dose Schedule Among Infants in China. Pediatr Infect Dis J. 2019 Nov;38(11):1150-1158. doi: 10.1097/INF.0000000000002458.
PubMed 31626050Zhu F, Hu Y, Li J, Ye Q, Young MM Jr, Zhou X, Chen Z, Yan B, Liang JZ, Gruber WC, Giardina PC, Scott DA. Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine Compared With 7-valent Pneumococcal Conjugate Vaccine Among Healthy Infants in China. Pediatr Infect Dis J. 2016 Sep;35(9):999-1010. doi: 10.1097/INF.0000000000001248.
PubMed 27254028
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Active-controlled, Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13vpnc Compared With A 7vpnc In Healthy Infants In China
- ClinicalTrials.gov ID
- NCT01692886
- Acronym / sponsor ID
- B1851015
- Conditions
- Pneumococcal Infection
- Keywords
- 13vPnC, 7vPnC, Healthy subjects, China
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,674 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is primarily designed to evaluate the IgG immune responses to the 13 pneumococcal serotypes induced by 13vPnC compared with the immune responses induced by 7vPnC when measured 1 month after the infant series, and to evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local reactions, systemic events and adverse events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 7vPnC (3-, 4-, 5-, 12-Month) | Active comparator | Biological: 7-valent Pneumococcal Conjugate Vaccine |
| 13vPnC (3-, 4-, 5-, 12-Month) | Experimental | Biological: 13-valent Pnumococcal Conjugate vaccine |
| 13vPnC (2-, 4-, 6-, 12-Month) | Experimental | Biological: 13-valent Pnumococcal Conjugate vaccine |
| 13vPnC (3-, 5-, 12-Month) | Experimental | Biological: 13-valent Pnumococcal Conjugate vaccine |
Who may qualify
- Ages
- 42 to 77 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Aged 42 to 77 days (approximately 2 months) at the time of enrollment.
- Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
Key exclusion criteria (3 listed)
- Previous vaccination with licensed or investigational pneumococcal vaccine.
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination with pneumococcal vaccines.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7-valent Pneumococcal Conjugate VaccineAlso: 7vPnCsuspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 4-Month Visit, 5-Month Visit, and 12-Month Visit, respectively | Biological | 7vPnC (3-, 4-, 5-, 12-Month) |
| 13-valent Pnumococcal Conjugate vaccineAlso: 13vPnCsuspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 4-Month Visit, 5-Month Visit, and 12-Month Visit, respectively | Biological | 13vPnC (3-, 4-, 5-, 12-Month) |
| 13-valent Pnumococcal Conjugate vaccineAlso: 13vPnCsuspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 2-Month Visit, 4-Month Visit, 6-Month Visit, and 12-Month Visit, respectively | Biological | 13vPnC (2-, 4-, 6-, 12-Month) |
| 13-valent Pnumococcal Conjugate vaccineAlso: 13vPnCsuspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 5-Month Visit, and 12-Month Visit, respectively | Biological | 13vPnC (3-, 5-, 12-Month) |
Primary outcome
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 1 And Group 2.
Time frame: 1 month after the infant series (6 Months of age)
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 3.
Time frame: 1 month after the infant series (7 Months of age)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 1 and Group 2.
Time frame: 1 month after the infant series (6 Months of age)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 3.
Time frame: 1 month after the infant series (7 Months of age)
Percentage of Participants Reporting Adverse Events in Group 1 and Group 2.
Time frame: Approximately 16 months from the participation into the study to the end of study
Percentage of Participants Reporting Adverse Events in Group 3 and Group 4.
Time frame: Approximately 16 months from the participation into study to the end of study
Percentage of Participants Reporting Pre-Specified Local Reactions In the 7 Days After Each Pneumococcal Vaccination in Group 1 and Group 2.
Time frame: Seven days after each pneumococcal vaccination dose within the period up to 12 months
Percentage of Participants Reporting Pre-Specified Local Reactions In the 7 Days After Each Pneumococcal Vaccination in Group 3 and Group 4.
Time frame: Seven days after each pneumococcal vaccination dose within the period up to 12 months
Percentage of Participants Reporting Pre-Specified Systemic Events (Including The Use Of Antipyretic Medication) In the 7 Days After Each Pneumococcal Vaccination in Group 1 and Group 2.
Time frame: Seven days after each pneumococcal vaccination dose within the period up to 12 months
Percentage of Participants Reporting Pre-Specified Systemic Events (Including The Use Of Antipyretic Medication) In the 7 Days After Each Pneumococcal Vaccination in Group 3 and Group 4.
Time frame: Seven days after each pneumococcal vaccination dose within the period up to 12 months
14 secondary outcomes
Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 1 And Group 2.
Time frame: 1 month after the infant series (6 Months of age)
Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 3.
Time frame: 1 month after the infant series (7 Months of age)
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 1 and Group 2.
Time frame: 1 month after the infant series (6 Months of age)
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 3.
Time frame: 1 month after the infant series (7 Months of age)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose in Group 2 and Group 3.
Time frame: 1 month after the toddler dose (13 Months of age)
Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Toddler Dose in Group 2 and Group 3.
Time frame: 1 month after the toddler dose (13 Months of age)
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Toddler Dose in Group 2 and Group 3.
Time frame: 1 month after the toddler dose (13 Months of age)
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 4.
Time frame: 1 month after the infant series (6 Months of age)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 4.
Time frame: 1 month after the infant series (6 Months of age)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose in Group 4.
Time frame: 1 month after the toddler dose (13 Months of age)
Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 4.
Time frame: 1 month after the infant series (6 Months of age)
Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Toddler Dose in Group 4.
Time frame: 1 month after the toddler dose (13 Months of age)
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 4.
Time frame: 1 month after the infant series (6 Months of age)
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Toddler Dose in Group 4.
Time frame: 1 month after the toddler dose (13 Months of age)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Derived from this study: PubMed 31626050Zhu F, Hu Y, Li J, Ye Q, Young MM Jr, Liang JZ, Gruber WC, Giardina PC, Scott DA. Immunogenicity and Safety of the 13-Valent Pneumococcal Conjugate Vaccine Administered in a 3 + 1 versus 2 + 1 Dose Schedule Among Infants in China. Pediatr Infect Dis J. 2019 Nov;38(11):1150-1158. doi: 10.1097/INF.0000000000002458.
- Derived from this study: PubMed 27254028Zhu F, Hu Y, Li J, Ye Q, Young MM Jr, Zhou X, Chen Z, Yan B, Liang JZ, Gruber WC, Giardina PC, Scott DA. Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine Compared With 7-valent Pneumococcal Conjugate Vaccine Among Healthy Infants in China. Pediatr Infect Dis J. 2016 Sep;35(9):999-1010. doi: 10.1097/INF.0000000000001248.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 7-valent Pneumococcal Conjugate Vaccine and 13-valent Pnumococcal Conjugate vaccine in people with Pneumococcal Infection, run by Pfizer 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 2 inclusion and 3 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 2 Jun 2026. 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?
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 1 And Group 2. (time frame: 1 month after the infant series (6 Months of age)). The study lists 10 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 NCT01692886, which also lists 2 linked publications.
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 2 Jun 2026.