Healthy SubjectsPhase 3NCT00761631

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Healthy Children Aged 15 Months to 17 Years

A Phase 3 study testing 13 valent pneumococcal conjugate vaccine in people with Healthy Subjects, run by Pfizer at 36 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

This open-label, multicenter study is designed to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy children aged more than 15 months up to less than 18 years. Read more about this study

Who is it for?: Ages 15 months to 18 years
Conditions the study is for: Healthy Subjects
What is being tested?: 13 valent pneumococcal conjugate vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,200 participants
Where: 36 sitesUnited States
Study dates: 18 Nov 2008to 10 Aug 2010
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 15 months to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Male or female subjects >15months to <18years in good health, available for entire study period and reachable by phone, parents/legal guardian able and willing to complete all study procedures, written documentation from health professional showing prior vaccination with Prevnar (except for group 4).
Group 4 only:
Negative urine pregnancy test for female subjects who are menstruating.

Who cannot join

Previous reaction or contra-indication to pneumococcal vaccine or vaccine related component , bleeding diathesis, received blood transfusion or blood related products, immune deficiency,congenital malformation.
Group 4 only:
Previous vaccination with Prevnar or any other pneumococcal vaccine.
Pregnant or breastfeeding adolescent females.

Trial locations and contacts

36 sites in 1 country.

City, postcode or hospital

36 sites in 1 country

United States36 sites

Central Arkansas Pediatric Clinic
Benton, Arkansas, 72019
MedCenter One/ Q&R Clinic
Bismarck, North Dakota, 58501
Cary Pediatric Center
Cary, North Carolina, 27518
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45206
Premier Medical Group
Clarksville, Tennessee, 37043
Shelly Senders & Associates
Cleveland, Ohio, 44121
Northern Illinois Research Associates
DeKalb, Illinois, 60115
Dakota Clinicl / Innovis Hospital
Fargo, North Dakota, 58103
Northwest Arkansas Pediatric Clinic
Fayetteville, Arkansas, 72703
Edinger Medical Group
Fountain Valley, California, 92708
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555
The Children's Clinic of Jonesboro, PA
Jonesboro, Arkansas, 72401
Primary Care Pediatric Clinic
Lebanon, New Hampshire, 03756
Arkansas Pediatric Clinic
Little Rock, Arkansas, 72205
Little Rock Children's Clinic, PA
Little Rock, Arkansas, 72205
Loma Linda University
Loma Linda, California, 92350
Loma Linda University
Loma Linda, California, 92354
Pediatric Infectious Diseases
Louisville, Kentucky, 40202-3830
Pediatric Infectious Diseases
Louisville, Kentucky, 40202
Pediatric and Adolescent Medicine, PA
Marietta, Georgia, 30062
The Monroe Clinic
Monroe, Wisconsin, 53566
Cottonwood Pediatrics
Murray, Utah, 84107
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Elmwood Pediatric Group
Rochester, New York, 14618
Aspen Medical Group
Saint Paul, Minnesota, 55108
University of Utah, Department of Pediatrics
Salt Lake City, Utah, 84132
Southwest Children's Research Associates
San Antonio, Texas, 78229
Families First Pediatrics
South Jordan, Utah, 84095
USF College of Medicine
Tampa, Florida, 33606
UCLA School of Medicine - Center for Vaccine Research
Torrance, California, 90509
Oklahoma State University Center for Health
Tulsa, Oklahoma, 74127
The Vancouver Clinic 700 N.E. 87th Avenue
Vancouver, Washington, 98664
The Vancouver Clinic 700 N.E. 87th Avenue
Vancouver, Washington, 98686
Advanced Pediatrics
Vienna, Virginia, 22180
Hunterdon Pediatrics Associates
Whitehouse Station, New Jersey, 08889
Pediatric and Adolescent Medicine, PA
Woodstock, Georgia, 30189

Other trials in United States

About this study

Official title: A Phase 3, Open Label Trial Evaluating The Safety, Tolerability And Immunogenicity Of 13-valent Pneumococcal Conjugate Vaccine In Healthy Children Aged 15 Months To 17 Years In Us.

Conditions: Healthy Subjects
Being tested: 13 valent pneumococcal conjugate vaccine

What participants receive

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

13 valent pneumococcal conjugate vaccineBiological
Intramuscular injection of 0.5mL at visit 1 and visit 2 for group 1 and and visit 1 for groups 2, 3, and 4.

Study groups in NCT00761631
Study group	Role	What they receive
Single	Experimental	Open label Receives: Biological: 13 valent pneumococcal conjugate vaccine

What is being measured

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

Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2
Percentage of participants achieving world health organization (WHO) predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on observed proportion of participants.
Measured: 28 to 42 days after dose 2 for Group 1 and 28 to 42 days after dose 1 for Group 2
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3
Antibody GMC for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for after dose 1 blood draw.
Measured: 28 to 42 days after dose 1 for Group 3
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4
Serotype-specific OPA GMTs for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for after dose 1 blood draw.
Measured: 28 to 42 days after dose 1 for Group 3 and 4

Timeline

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

18 Nov 200810 Aug 2010

First posted29 Sep 2008 (estimated)
Study start18 Nov 2008
Primary completion10 Aug 2010
Study completion10 Aug 2010

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 (2)Papers the sponsor has linked to this study.
Other trials for Healthy SubjectsStudies 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
Masking: None (open label)
Enrolment: 1,200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00761631
Sponsor's protocol ID: 6096A1-3011
Other IDs: 2009-017304-88, B1851010, 2009
Status last verified: Mar 2019
First submitted: 25 Sep 2008
Last updated: 21 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Frenck R Jr, Thompson A, Senders S, Harris-Ford L, Sperling M, Patterson S, Devlin C, Jansen KU, Gruber WC, Emini EA, Scott DA, Gurtman A. 13-Valent pneumococcal conjugate vaccine in older children and adolescents either previously immunized with or naive to 7-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2014 Feb;33(2):183-9. doi: 10.1097/INF.0000000000000056.
PubMed 24136369
Frenck R Jr, Thompson A, Yeh SH, London A, Sidhu MS, Patterson S, Gruber WC, Emini EA, Scott DA, Gurtman A; 3011 Study Group. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in children previously immunized with 7-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2011 Dec;30(12):1086-91. doi: 10.1097/INF.0b013e3182372c6a.
PubMed 21983216

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?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Open Label Trial Evaluating The Safety, Tolerability And Immunogenicity Of 13-valent Pneumococcal Conjugate Vaccine In Healthy Children Aged 15 Months To 17 Years In Us.
ClinicalTrials.gov ID: NCT00761631
Acronym / sponsor ID: 6096A1-3011
Conditions: Healthy Subjects
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,200 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 18 Nov 2008 (actual)
Primary completion: 10 Aug 2010 (actual)
Study completion: 10 Aug 2010 (actual)
First posted: 29 Sep 2008 (estimated)
Results: Posted 10 Aug 2011

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
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single	Experimental	Biological: 13 valent pneumococcal conjugate vaccineOpen label

Who may qualify

Ages: 15 months to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Male or female subjects >15months to <18years in good health, available for entire study period and reachable by phone, parents/legal guardian able and willing to complete all study procedures, written documentation from health professional showing prior vaccination with Prevnar (except for group 4).
Negative urine pregnancy test for female subjects who are menstruating.

Key exclusion criteria (4 listed)

Previous reaction or contra-indication to pneumococcal vaccine or vaccine related component , bleeding diathesis, received blood transfusion or blood related products, immune deficiency,congenital malformation.
Previous vaccination with Prevnar or any other pneumococcal vaccine.
Pregnant or breastfeeding adolescent females.

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
13 valent pneumococcal conjugate vaccineIntramuscular injection of 0.5mL at visit 1 and visit 2 for group 1 and and visit 1 for groups 2, 3, and 4.	Biological	Single

Primary outcome

Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2
Time frame: 28 to 42 days after dose 2 for Group 1 and 28 to 42 days after dose 1 for Group 2
Percentage of participants achieving world health organization (WHO) predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on observed proportion of participants.
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3
Time frame: 28 to 42 days after dose 1 for Group 3
Antibody GMC for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for after dose 1 blood draw.
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4
Time frame: 28 to 42 days after dose 1 for Group 3 and 4
Serotype-specific OPA GMTs for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for after dose 1 blood draw.

Results and safety

Results posted to the registry on 10 Aug 2011, 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 Group 1 (Cohort 1)	126	111
13vPnC Group 2 (Cohort 1)	181	174
13vPnC Group 1 (Cohort 2)	176	160
13vPnC Group 2 (Cohort 2)	119	116
13vPnC Group 3	299	277
13vPnC Group 4	299	294

Primary outcome: Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2

Time frame: 28 to 42 days after dose 2 for Group 1 and 28 to 42 days after dose 1 for Group 2. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	13vPnC Group 1 (Cohort 1) n = 109	13vPnC Group 2 (Cohort 1) n = 175
Common serotypes - serotype 4	98.2 (93.5 to 99.8)	100.0 (97.9 to 100.0)
Common serotypes - serotype 6B	100.0 (96.7 to 100.0)	100.0 (97.9 to 100.0)
Common serotypes - serotype 9V	100.0 (96.7 to 100.0)	100.0 (97.9 to 100.0)
Common serotypes - serotype 14	100.0 (96.7 to 100.0)	100.0 (97.9 to 100.0)
Common serotypes - serotype 18C	100.0 (96.7 to 100.0)	100.0 (97.9 to 100.0)
Common serotypes - serotype 19F	100.0 (96.7 to 100.0)	100.0 (97.9 to 100.0)
Common serotypes - serotype 23F	99.1 (95.0 to 100.0)	100.0 (97.9 to 100.0)
Additional serotypes - serotype 1	100.0 (96.7 to 100.0)	98.9 (95.9 to 99.9)

Population analysed: Evaluable Immunogenicity Population (EIP): all participants who met all inclusion criteria, received all assigned doses of study vaccine, had at least 1 valid and determinate assay result from blood draw within 27-56 days after last scheduled vaccination for proposed analysis and no major protocol violations.

Primary outcome: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3

Time frame: 28 to 42 days after dose 1 for Group 3. Geometric mean (95% Confidence Interval). Unit: mcg/mL

Measure	13vPnC Group 3 n = 171
Common serotypes - serotype 4	8.45 (7.24 to 9.87)
Common serotypes - serotype 6B	53.56 (45.48 to 63.07)
Common serotypes - serotype 9V	9.51 (8.38 to 10.78)
Common serotypes - serotype 14	29.36 (24.78 to 34.78)
Common serotypes - serotype 18C	8.23 (7.13 to 9.51)
Common serotypes - serotype 19F	17.58 (14.95 to 20.67)
Common serotypes - serotype 23F	11.26 (9.79 to 12.95)
Additional serotypes - serotype 1	3.57 (3.05 to 4.18)

Population analysed: EIP: participants who met all inclusion criteria, received all assigned doses of study vaccine;had at least 1 valid, determinate assay result from blood draw within 27-56 days after last scheduled vaccination for proposed analysis;no major protocol violations. N (number of participants analyzed)=participants with determinate antibody concentration.

Primary outcome: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4

Time frame: 28 to 42 days after dose 1 for Group 3 and 4. Geometric mean (95% Confidence Interval). Unit: titer

Measure	13vPnC Group 3 n = 189	13vPnC Group 4 n = 181
Common serotypes - serotype 4	6912 (6101.2 to 7831.4)	4629 (4017.2 to 5334.3)
Common serotypes - serotype 6B	14224 (12316.4 to 16427.3)	14996 (13164.1 to 17083.1)
Common serotypes - serotype 9V	4485 (4001.1 to 5027.5)	4733 (4203.3 to 5328.4)
Common serotypes - serotype 14	6894 (6028.3 to 7884.0)	4759 (4120.4 to 5497.0)
Common serotypes - serotype 18C	6263 (5436.4 to 7215.1)	8815 (7738.2 to 10041.0)
Common serotypes - serotype 19F	2280 (1949.4 to 2667.6)	1559 (1293.3 to 1878.9)
Common serotypes - serotype 23F	3808 (3354.7 to 4322.6)	3245 (2818.8 to 3735.5)
Additional serotypes - serotype 1	319 (271.2 to 376.0)	187 (160.4 to 218.6)

13vPnC Group 3 vs 13vPnC Group 4: GMT Ratio: 1.5 (95% CI 1.24 to 1.80)
13vPnC Group 3 vs 13vPnC Group 4: GMT Ratio: 0.9 (95% CI 0.78 to 1.15)
13vPnC Group 3 vs 13vPnC Group 4: GMT Ratio: 0.9 (95% CI 0.80 to 1.12)

Adverse events

Time frame: Group 1: Baseline up to Day 280; Group 2, 3 and 4: Baseline up to Day 210. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 7 days after each vaccine dose). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
13vPnC Group 1 (Cohort 1) Dose 1	0 of 124 (0%)	112 of 124 (90.3%)	Not reported
13vPnC Group 1 (Cohort 1) Dose 2	2 of 112 (1.8%)	91 of 112 (81.3%)	Not reported
13vPnC Group 2 (Cohort 1) Dose 1	1 of 179 (0.6%)	158 of 179 (88.3%)	Not reported
13vPnC Group 1 (Cohort 2) Dose 1	1 of 175 (0.6%)	165 of 175 (94.3%)	Not reported
13vPnC Group 1 (Cohort 2) Dose 2	4 of 165 (2.4%)	137 of 165 (83%)	Not reported
13vPnC Group 2 (Cohort 2) Dose 1	0 of 118 (0%)	107 of 118 (90.7%)	Not reported
6-Month Follow-up 13vPnC Group 1 (Cohort 1 and 2)	3 of 299 (1%)	2 of 299 (0.7%)	Not reported
6-Month Follow-up 13vPnC Group 2 (Cohort 1 and 2)	1 of 297 (0.3%)	2 of 297 (0.7%)	Not reported
13vPnC Group 3	1 of 294 (0.3%)	242 of 294 (82.3%)	Not reported
6-Month Follow-up 13vPnC Group 3	0 of 294 (0%)	7 of 294 (2.4%)	Not reported
13vPnC Group 4	0 of 298 (0%)	258 of 298 (86.6%)	Not reported
6-Month Follow-up 13vPnC Group 4	1 of 298 (0.3%)	4 of 298 (1.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24136369Frenck R Jr, Thompson A, Senders S, Harris-Ford L, Sperling M, Patterson S, Devlin C, Jansen KU, Gruber WC, Emini EA, Scott DA, Gurtman A. 13-Valent pneumococcal conjugate vaccine in older children and adolescents either previously immunized with or naive to 7-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2014 Feb;33(2):183-9. doi: 10.1097/INF.0000000000000056.
Derived from this study: PubMed 21983216Frenck R Jr, Thompson A, Yeh SH, London A, Sidhu MS, Patterson S, Gruber WC, Emini EA, Scott DA, Gurtman A; 3011 Study Group. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in children previously immunized with 7-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2011 Dec;30(12):1086-91. doi: 10.1097/INF.0b013e3182372c6a.

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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

36 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 13 valent pneumococcal conjugate vaccine in people with Healthy Subjects, run by Pfizer at 36 sites in United States.

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 3 inclusion and 4 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 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States. 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 10 Aug 2011). 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?

Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2 (time frame: 28 to 42 days after dose 2 for Group 1 and 28 to 42 days after dose 1 for Group 2). The study lists 3 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 NCT00761631, 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 21 Jul 2026.