Pneumococcal InfectionsPhase 3NCT01432262

13-valent Pneumococcal Conjugate Vaccine Study in Adults => 50 Years of Age in Mexico

A Phase 3 study testing vaccine-13vPnC in people with Pneumococcal Infections, run by Pfizer at 4 sites in Mexico.

Completed

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

Trial summary

The purpose of this study will be to assess the safety, tolerability, and immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) when given to healthy adults older than 50 years of age who haven't received 23-valent pneumococcal polysaccharide vaccine in Mexico. Read more about this study

Who is it for?: Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for: Pneumococcal Infections
What is being tested?: vaccine-13vPnC
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 324 participants
Where: 4 sitesMexico
Study dates: Jul 2011to Dec 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male or female older than 50 years of age
Eligibility must be determined by medical history, physical exam and clinical judgment
Able to complete an electronic diary
Available for duration of study
Negative pregnancy test for subjects in group 2 age 50 to 64 years
Practice abstinence or use reliable birth control if age is 50 to 64 years

Who cannot join

History of allergic reaction to any vaccine
Previous vaccination with licensed or experimental pneumococcal vaccine
S. pneumonia infection within past 5 years before investigational product administration
Known or suspected immunodeficiency or received treatment including cytotoxic agents or systemic corticosteroids, serious chronic disorder such as malignancy cancer
Receipt of plasma products or immunoglobulins within 60 days
Bleeding conditions or diathesis
Receipt of investigational product within 28 days before study entry
Other severe acute or chronic medical or psychiatric condition

Trial locations and contacts

4 sites in 1 country.

Mexico4 sites

Hospital General de Durango
Durango, 34000
Instituto Mexicano de Investigación Clínica, S.A. de C.V
México, D.f., 06700
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico City, 14000
Star Medica
Morelia, Michoacán, CP 58070

Other trials in Mexico

About this study

Official title: A Phase 3, Open Label, Single Arm, Multicenter, Trial to Assess The Safety, Tolerability And Immunogenicity Of 13-Valent Pneumococcal Conjugate Vaccine In Healthy Adults Aged => 50 Years of Age Who Are Naive To 23-Valent Pneumococcal Polysaccharide Vaccine in Mexico.

Conditions: Pneumococcal Infections
Being tested: vaccine-13vPnC
Keywords: prevention of pneumococcal diseases
Medical subject headings: Pneumococcal Infections

What participants receive

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

vaccine-13vPnCBiological
Also called 13-valent pneumococcal conjugate vaccine
Single dose of 0.5 ml of 13vPnC administered in deltoid muscle of arm at visit 1 (day 1)
vaccine-13vPnCBiological
Also called 13-valent pneumococcal conjugate vaccine
Single dose of 0.5 ml of 13vPnC administered in deltoid muscle of arm at visit 1 (day 1)

Study groups in NCT01432262
Study group	Role	What they receive
Group 1	Experimental	=> 65 years of age Receives: Biological: vaccine-13vPnC
Group 2	Experimental	50 to 64 years of age Receives: Biological: vaccine-13vPnC

What is being measured

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

Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination
Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a quantitative functional OPA assay. Confidence intervals (CIs) for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Individual OPA assay values below the assay LLOQ (lower limit of quantification) were set at a titer of 0.5*limit of detection (LOD [8]) = (titer of 4) for the purpose of calculating the OPA GMT.
Measured: One month (28 to 42 days) after vaccination
Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination
Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present), Mild (2.5 to 5.0 centimeters [cm]), Moderate (5.1 to 10.0 cm), Severe (>10 cm). Pain at injection site scaled as Any (pain present), Mild (does not interfere with activity), Moderate (interferes with activity), Severe (prevents daily activity).
Measured: Within 14 days after vaccination
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination
Systemic events reported using electronic diary. Fever-Any:>=38 degrees Celsius (C), Mild (M):>=38 to <38.5 degrees C, Moderate(Mod):>=38.5 to <39 degrees C, Severe (S):>=39 to <=40 degrees C, Potentially life threatening:>40 degrees C. Headache, fatigue, muscle pain, joint pain- Any: present, M:did not interfere with activity, Mod:some interference, S:activity prevented. Vomiting- Any:present, M:1-2 times/day (d), Mod:>2/d, S:required intravenous hydration. Diarrhoea- Any:present, M:2-3 loose stools/d, Mod:4-5/d, S:>=6/d. All reports of fever >40 degrees C were confirmed as data entry errors.
Measured: Within 14 days after vaccination
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between vaccination and up to 1 month (28 to 42 days) after vaccination that were absent before treatment or that worsened relative to pre-treatment state.
Measured: Baseline up to 1 Month (28 to 42 days) after vaccination

Secondary outcomes (2)

Percentage of Participants Achieving Serotype-Specific Opsonophagocytic Activity (OPA) Titer With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination
Percentage of participants achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all participants using microcolony OPA assay. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=1:18, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.
Measured: One month (28 to 42 days) after vaccination
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination to 1 Month Post-Vaccination
Geometric mean fold rises (GMFRs) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from pre-vaccination to 1 month post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Measured: Pre-vaccination to 1 month (28 to 42 days) after vaccination

Timeline

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

Jul 2011Dec 2011

First posted12 Sep 2011 (estimated)
Study startJul 2011
Primary completionDec 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pneumococcal InfectionsStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 324 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01432262
Sponsor's protocol ID: B1851048
Other IDs: 6115A1-3020
Status last verified: Jan 2013
First submitted: 22 Jun 2011
Last updated: 25 Jan 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Tinoco JC, Juergens C, Ruiz Palacios GM, Vazquez-Narvaez J, Enkerlin-Pauwells HL, Sundaraiyer V, Pathirana S, Kalinina E, Gruber WC, Scott DA, Schmoele-Thoma B. Open-label trial of immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in adults >/= 50 years of age in Mexico. Clin Vaccine Immunol. 2015 Feb;22(2):185-92. doi: 10.1128/CVI.00711-14. Epub 2014 Dec 10.
PubMed 25499011

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
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All Pneumococcal Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Open Label, Single Arm, Multicenter, Trial to Assess The Safety, Tolerability And Immunogenicity Of 13-Valent Pneumococcal Conjugate Vaccine In Healthy Adults Aged => 50 Years of Age Who Are Naive To 23-Valent Pneumococcal Polysaccharide Vaccine in Mexico.
ClinicalTrials.gov ID: NCT01432262
Acronym / sponsor ID: B1851048
Conditions: Pneumococcal Infections
Keywords: prevention of pneumococcal diseases
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 324 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 12 Sep 2011 (estimated)
Results: Posted 8 Jan 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1	Experimental	Biological: vaccine-13vPnC=> 65 years of age
Group 2	Experimental	Biological: vaccine-13vPnC50 to 64 years of age

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Male or female older than 50 years of age
Eligibility must be determined by medical history, physical exam and clinical judgment
Able to complete an electronic diary
Available for duration of study
Negative pregnancy test for subjects in group 2 age 50 to 64 years

Key exclusion criteria (8 listed)

History of allergic reaction to any vaccine
Previous vaccination with licensed or experimental pneumococcal vaccine
S. pneumonia infection within past 5 years before investigational product administration
Known or suspected immunodeficiency or received treatment including cytotoxic agents or systemic corticosteroids, serious chronic disorder such as malignancy cancer
Receipt of plasma products or immunoglobulins within 60 days

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
vaccine-13vPnCAlso: 13-valent pneumococcal conjugate vaccineSingle dose of 0.5 ml of 13vPnC administered in deltoid muscle of arm at visit 1 (day 1)	Biological	Group 1
vaccine-13vPnCAlso: 13-valent pneumococcal conjugate vaccineSingle dose of 0.5 ml of 13vPnC administered in deltoid muscle of arm at visit 1 (day 1)	Biological	Group 2

Primary outcome

Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination
Time frame: One month (28 to 42 days) after vaccination
Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a quantitative functional OPA assay. Confidence intervals (CIs) for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Individual OPA assay values below the assay LLOQ (lower limit of quantification) were set at a titer of 0.5*limit of detection (LOD [8]) = (titer of 4) for the purpose of calculating the OPA GMT.
Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination
Time frame: Within 14 days after vaccination
Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present), Mild (2.5 to 5.0 centimeters [cm]), Moderate (5.1 to 10.0 cm), Severe (>10 cm). Pain at injection site scaled as Any (pain present), Mild (does not interfere with activity), Moderate (interferes with activity), Severe (prevents daily activity).
Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination
Time frame: Within 14 days after vaccination
Systemic events reported using electronic diary. Fever-Any:>=38 degrees Celsius (C), Mild (M):>=38 to <38.5 degrees C, Moderate(Mod):>=38.5 to <39 degrees C, Severe (S):>=39 to <=40 degrees C, Potentially life threatening:>40 degrees C. Headache, fatigue, muscle pain, joint pain- Any: present, M:did not interfere with activity, Mod:some interference, S:activity prevented. Vomiting- Any:present, M:1-2 times/day (d), Mod:>2/d, S:required intravenous hydration. Diarrhoea- Any:present, M:2-3 loose stools/d, Mod:4-5/d, S:>=6/d. All reports of fever >40 degrees C were confirmed as data entry errors.
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame: Baseline up to 1 Month (28 to 42 days) after vaccination
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between vaccination and up to 1 month (28 to 42 days) after vaccination that were absent before treatment or that worsened relative to pre-treatment state.

2 secondary outcomes

Percentage of Participants Achieving Serotype-Specific Opsonophagocytic Activity (OPA) Titer With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination
Time frame: One month (28 to 42 days) after vaccination
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination to 1 Month Post-Vaccination
Time frame: Pre-vaccination to 1 month (28 to 42 days) after vaccination

Results and safety

Results posted to the registry on 8 Jan 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
13vPnC, Cohort 1	162	160
13vPnC, Cohort 2	162	161

Primary outcome: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination

Time frame: One month (28 to 42 days) after vaccination. Geometric mean (95% Confidence Interval). Unit: titer

Measure	13vPnC, Cohort 1 n = 155	13vPnC, Cohort 2 n = 159
1	120 (92.3 to 155.3)	84 (62.8 to 112.5)
3	88 (72.4 to 106.9)	89 (70.8 to 111.5)
4	1729 (1377.6 to 2170.9)	1209 (977.1 to 1495.9)
5	288 (208.6 to 398.3)	285 (208.7 to 388.9)
6A	3380 (2732.9 to 4179.6)	3343 (2625.2 to 4256.6)
6B	3982 (3273.2 to 4845.0)	3384 (2708.6 to 4227.2)
7F	3130 (2660.9 to 3681.4)	1929 (1564.7 to 2378.1)
9V	2416 (1901.0 to 3071.4)	1402 (1030.8 to 1906.8)

Population analysed: Evaluable Immunogenicity Population (EIP): eligible participants who received vaccine, had blood drawn within the pre-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, and had no other major protocol violations.

Primary outcome: Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination

Time frame: Within 14 days after vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	13vPnC, Cohort 1 n = 152	13vPnC, Cohort 2 n = 139
Redness: Any (n=125, 120)	14.4 (8.8 to 21.8)	15.8 (9.8 to 23.6)
Redness: Mild (n=124, 120)	9.7 (5.1 to 16.3)	13.3 (7.8 to 20.7)
Redness: Moderate (n=125, 115)	8.8 (4.5 to 15.2)	7.0 (3.1 to 13.2)
Redness: Severe (n=125, 112)	2.4 (0.5 to 6.9)	0.0 (0.0 to 3.2)
Swelling: Any (n=130, 120)	21.5 (14.8 to 29.6)	13.3 (7.8 to 20.7)
Swelling: Mild (n=127, 120)	18.1 (11.8 to 25.9)	11.7 (6.5 to 18.8)
Swelling: Moderate (n=127, 114)	8.7 (4.4 to 15.0)	4.4 (1.4 to 9.9)
Swelling: Severe (n=125, 113)	2.4 (0.5 to 6.9)	0.9 (0.0 to 4.8)

Population analysed: Safety Population included all participants who received vaccine. N (Number of Participants Analyzed)=participants reporting yes for at least 1 day or no for all 14 days and n=participants reporting yes for at least 1 day or no for all 14 days for specified local reaction for each group respectively. Participants may be represented in \>1 category.

Primary outcome: Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination

Time frame: Within 14 days after vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	13vPnC, Cohort 1 n = 155	13vPnC, Cohort 2 n = 145
Fever: Any (n=126, 118)	2.4 (0.5 to 6.8)	10.2 (5.4 to 17.1)
Fever: Mild (n=126, 113)	1.6 (0.2 to 5.6)	3.5 (1.0 to 8.8)
Fever: Moderate (n=125, 113)	0.8 (0.0 to 4.4)	1.8 (0.2 to 6.2)
Fever: Severe (n=124, 113)	0.8 (0.0 to 4.4)	1.8 (0.2 to 6.2)
Fever: Potentially life threatening (n=124, 116)	0.0 (0.0 to 2.9)	4.3 (1.4 to 9.8)
Fatigue: Any (n=144, 132)	47.2 (38.9 to 55.7)	38.6 (30.3 to 47.5)
Fatigue: Mild (n=142, 130)	39.4 (31.3 to 48.0)	36.2 (27.9 to 45.0)
Fatigue: Moderate (n=134, 125)	26.9 (19.6 to 35.2)	20.0 (13.4 to 28.1)

Population analysed: Safety Population included all participants who received vaccine. N (Number of Participants Analyzed)=participants reporting yes for at least 1 day or no for all 14 days and n=participants reporting yes for at least 1 day or no for all 14 days for specified systemic event for each group respectively. Participants may be represented in \>1 category.

Primary outcome: Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

Time frame: Baseline up to 1 Month (28 to 42 days) after vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	13vPnC, Cohort 1 n = 162	13vPnC, Cohort 2 n = 161
AEs	11.1 (6.7 to 17.0)	6.2 (3.0 to 11.1)
SAEs	0.0 (0.0 to 2.3)	1.2 (0.2 to 4.4)

Population analysed: Safety Population included all participants who received the vaccine.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events: recorded from signing of informed consent form to 28-42 days post 13vPnC. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1 to 14 post 13vPnC.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
13vPnC, Cohort 1	0 of 162 (0%)	119 of 162 (73.5%)	Not reported
13vPnC, Cohort 2	2 of 161 (1.2%)	88 of 161 (54.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25499011Tinoco JC, Juergens C, Ruiz Palacios GM, Vazquez-Narvaez J, Enkerlin-Pauwells HL, Sundaraiyer V, Pathirana S, Kalinina E, Gruber WC, Scott DA, Schmoele-Thoma B. Open-label trial of immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in adults >/= 50 years of age in Mexico. Clin Vaccine Immunol. 2015 Feb;22(2):185-92. doi: 10.1128/CVI.00711-14. Epub 2014 Dec 10.
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 vaccine-13vPnC in people with Pneumococcal Infections, run by Pfizer at 4 sites in Mexico.

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 6 inclusion and 8 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 25 Jan 2013. 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 Mexico. 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?

Yes. Results are posted in the registry (first posted 8 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination (time frame: One month (28 to 42 days) after vaccination). The study lists 4 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 NCT01432262, 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 25 Jan 2013.