Healthy SubjectsPhase 1/2NCT00205803

Study Evaluating Pneumococcal Vaccine in Healthy Infants

A Phase 1/2 study testing 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) and 7-Valent Pneumococcal Conjugate Vaccine (7vPnC) in people with Healthy Subjects and Pneumococcal Infections, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in United States.

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

The purpose of this study is to evaluate the safety and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in healthy infants. This is the first study with this vaccine in infants. Read more about this study

Who is it for?: Ages 42 to 98 daysHealthy volunteers can take part
Conditions the study is for: Healthy Subjects, Pneumococcal Infections
What is being tested?: 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) and 7-Valent Pneumococcal Conjugate Vaccine (7vPnC)
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 249 participants
Where: 1 siteUnited States
Study dates: Sep 2004to May 2007
Phase: Phase 1/2
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 42 to 98 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Aged 6 weeks to 14 weeks (42-98 days of age) at time of enrollment,
In good health as determined by medical history, physical examination and judgment of the investigator,
Subject must have been born ≥36 weeks of gestational age,
Subject must be available for entire study period and whose parent/legal guardian can be reached by telephone,
Parent/legal guardian must be able to understand and sign an informed consent form prior to participation and complete a parent worksheet during study participation.

Who cannot join

Previous vaccination with licensed or investigational pneumococcal vaccine,
Previous vaccination with Hib conjugate, DTaP or IPV vaccines,
Contraindication to immunization with HepB, Hib conjugate, DTaP or IPV vaccines,
Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus or other significant disorders. Does not include resolving syndromes due to birth trauma such as Erb palsy,
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection,
History of culture-proven invasive disease caused by S. pneumoniae,

Show all 11Show fewer

Previous anaphylactic reaction to any vaccine or vaccine components,
Major known congenital malformation or serious chronic disorders,
Participation in another investigational study (however, observation-only trials are permitted),
Known or suspected immune deficiency/suppression,
Receipt of blood products or gamma globulin (including Hepatitis B immunoglobulin and monoclonal antibody; eg, Synagis®).

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
New York, New York, 10045

Other trials in United States

About this study

Official title: A Phase I/II, 2-stage, Randomized, Double-Blind Trial of the Safety, Tolerability and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine (Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in Healthy Infants

Conditions: Healthy Subjects, Pneumococcal Infections
Being tested: 13-Valent Pneumococcal Conjugate Vaccine (13vPnC), 7-Valent Pneumococcal Conjugate Vaccine (7vPnC)
Keywords: Infant Vaccine
Medical subject headings: Pneumococcal Infections

What participants receive

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

13-Valent Pneumococcal Conjugate Vaccine (13vPnC)Biological
7-Valent Pneumococcal Conjugate Vaccine (7vPnC)Biological

Study groups in NCT00205803
Study group	Role	What they receive
13vPnC	Experimental	Not described Receives: Biological: 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)
7vPnC	Active comparator	Not described Receives: Biological: 7-Valent Pneumococcal Conjugate Vaccine (7vPnC)

What is being measured

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

Percentage of Participants Reporting Pre-Specified Local Reactions
Local reaction events were collected using a paper worksheet. Tenderness was scaled as Any (tenderness present); Significant (Sig.) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod.)(2.5 to 7.0 cm); Severe (Sev.)(> 7.0 cm). Participants may be represented in more than 1 category.
Measured: Within 15 days after each dose
Percentage of Participants Reporting Pre-Specified Systemic Events
Systemic events (fever [Fv] ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased (decr.) appetite, irritability, increased sleep, decreased sleep, use of medication (Med.)to prevent symptoms (sx), and use of medication to treat symptoms) were reported using a paper worksheet. Participants may be represented in more than 1 category.
Measured: Within 15 days after each dose
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Percentage of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% 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) are presented. Exact 2-sided CI based on the observed proportion of participants.
Measured: one month after 3-dose infant series (at 7 months of age)

Secondary outcomes (12)

Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Percentages of participants achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% 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) are presented. Exact 2-sided CI based on the observed proportion of participants.
Measured: One month after the toddler dose (at 13 to 16 months of age)
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Antibody geometric mean concentration (GMC) as measured by enzyme-linked immunosorbent assay (ELISA) for 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) are presented. GMC ratios (13vPnC/7vPnC) and corresponding 2-sided 95% CI were evaluated.
Measured: One month after 3-dose infant series (at 7 months of age)
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Antibody geometric mean concentration (GMC) as measured by ELISA with their corresponding 95% CI immediately before and after the toddler dose for 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) are presented.
Measured: Immediately before (12 to 15 months of age) and one month after the toddler dose (13 to 16 months of age)
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Percentage of participants achieving predefined antibody threshold levels for Haemophilus Influenzae Type b (Hib) polyribosylribitol phosphate (PRP), Diphtheria Toxoid, Polio (Types 1, 2, and 3), Pertussis (filamentous hemagglutinin [FHA], Pertussis Toxoid, and Pertactin), Tetanus, and Hepatitis B with the corresponding 95% CI for each concomitant antigen are presented.
Measured: One month after the infant series (7 months of age)
Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Measured: one month after the infant series (7 months of age)
Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
GMCs of anti-hepatitis B surface antigen (HBsAg) using a Food and Drug Administration (FDA) approved in vitro diagnostic kit are presented.
Measured: one month after the infant series (7 months of age)
Geometric Mean Antibody Concentration Diphtheria Toxoid and Anti-Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Measured: one month after the infant series (7 months of age)
Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Measured: one month after the infant series (7 months of age)
Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Measured: one month after the infant series (7 months of age)
Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% 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) are presented.
Measured: one month after the infant series (7 months of age)
Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% 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 assessed. Results are reported for the serotypes with a determinate antibody titer.
Measured: One month after the toddler dose (13 to 16 months of age)
Geometric Mean Antibody Titer (OPA) in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) for 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 assessed. Results are reported for the serotypes with a determinate antibody titer.
Measured: One month after the Toddler Dose (13 to 16 months of age)

Timeline

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

Sep 2004May 2007

First posted20 Sep 2005 (estimated)
Study startSep 2004
Study completionMay 2007

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 Healthy SubjectsStudies of the same condition, open and under way.
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 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 249 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00205803
Sponsor's protocol ID: 6096A1-003
Status last verified: Jul 2012
First submitted: 19 Sep 2005
Last updated: 15 Aug 2012
Results posted: Yes, on ClinicalTrials.gov

Publications

Bryant KA, Block SL, Baker SA, Gruber WC, Scott DA; PCV13 Infant Study Group. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine. Pediatrics. 2010 May;125(5):866-75. doi: 10.1542/peds.2009-1405.
PubMed 20435707

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 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II, 2-stage, Randomized, Double-Blind Trial of the Safety, Tolerability and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine (Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in Healthy Infants
ClinicalTrials.gov ID: NCT00205803
Acronym / sponsor ID: 6096A1-003
Conditions: Healthy Subjects, Pneumococcal Infections
Keywords: Infant Vaccine
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 249 participants (actual)
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Study start: Sep 2004
Study completion: May 2007 (actual)
First posted: 20 Sep 2005 (estimated)
Results: Posted 15 Aug 2012

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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
13vPnC	Experimental	Biological: 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)
7vPnC	Active comparator	Biological: 7-Valent Pneumococcal Conjugate Vaccine (7vPnC)

Who may qualify

Ages: 42 to 98 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

Aged 6 weeks to 14 weeks (42-98 days of age) at time of enrollment,
In good health as determined by medical history, physical examination and judgment of the investigator,
Subject must have been born ≥36 weeks of gestational age,
Subject must be available for entire study period and whose parent/legal guardian can be reached by telephone,
Parent/legal guardian must be able to understand and sign an informed consent form prior to participation and complete a parent worksheet during study participation.

Key exclusion criteria (11 listed)

Previous vaccination with licensed or investigational pneumococcal vaccine,
Previous vaccination with Hib conjugate, DTaP or IPV vaccines,
Contraindication to immunization with HepB, Hib conjugate, DTaP or IPV vaccines,
Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus or other significant disorders. Does not include resolving syndromes due to birth trauma such as Erb palsy,
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection,

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 Vaccine (13vPnC)	Biological	13vPnC
7-Valent Pneumococcal Conjugate Vaccine (7vPnC)	Biological	7vPnC

Primary outcome

Percentage of Participants Reporting Pre-Specified Local Reactions
Time frame: Within 15 days after each dose
Local reaction events were collected using a paper worksheet. Tenderness was scaled as Any (tenderness present); Significant (Sig.) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod.)(2.5 to 7.0 cm); Severe (Sev.)(> 7.0 cm). Participants may be represented in more than 1 category.
Percentage of Participants Reporting Pre-Specified Systemic Events
Time frame: Within 15 days after each dose
Systemic events (fever [Fv] ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased (decr.) appetite, irritability, increased sleep, decreased sleep, use of medication (Med.)to prevent symptoms (sx), and use of medication to treat symptoms) were reported using a paper worksheet. Participants may be represented in more than 1 category.
Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Time frame: one month after 3-dose infant series (at 7 months of age)
Percentage of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% 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) are presented. Exact 2-sided CI based on the observed proportion of participants.

12 secondary outcomes

Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Time frame: One month after the toddler dose (at 13 to 16 months of age)
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Time frame: One month after 3-dose infant series (at 7 months of age)
Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose
Time frame: Immediately before (12 to 15 months of age) and one month after the toddler dose (13 to 16 months of age)
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Time frame: One month after the infant series (7 months of age)
Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Time frame: one month after the infant series (7 months of age)
Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Time frame: one month after the infant series (7 months of age)
Geometric Mean Antibody Concentration Diphtheria Toxoid and Anti-Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Time frame: one month after the infant series (7 months of age)
Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Time frame: one month after the infant series (7 months of age)
Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Time frame: one month after the infant series (7 months of age)
Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Time frame: one month after the infant series (7 months of age)
Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Time frame: One month after the toddler dose (13 to 16 months of age)
Geometric Mean Antibody Titer (OPA) in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Time frame: One month after the Toddler Dose (13 to 16 months of age)

Results and safety

Results posted to the registry on 15 Aug 2012, 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	122	104
7vPnC	127	116

Primary outcome: Percentage of Participants Reporting Pre-Specified Local Reactions

Time frame: Within 15 days after each dose. Number. Unit: percentage of participants

Measure	13vPnC Dose 1 n = 121	7vPnc Dose 1 n = 126	13vPnC Dose 2 n = 115	7vPnC Dose 2 n = 122	13vPnC Dose 3 n = 110	7vPnC Dose 3 n = 118	13vPnC Toddler Dose n = 86	7vPnC Toddler Dose n = 103
Tenderness-Any (n=119,124,110,118,107,117,85,101)	34.5	43.5	28.2	36.4	24.3	25.6	22.4	29.7
Tenderness-Sig. (n=119,124,110,118,107,117,85,101)	8.4	5.6	1.8	8.5	4.7	6.0	2.4	4.0
Induration-Any (n=119,124,110,118,107,117,85,100)	21.8	19.4	16.4	19.5	16.8	18.8	18.8	17.0
Induration-Mild (n=119,123,110,117,107,116,85,100)	20.2	17.9	16.4	17.1	16.8	17.2	18.8	17.0
Induration-Mod. (n=119,123,110,117,107,116,85,100)	3.4	2.4	3.6	3.4	0.0	4.3	2.4	3.0
Induration-Sev. (n=119,123,110,117,107,116,85,100)	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0
Erythema-Any (n=119,124,111,118,107,117, 85,100)	21.0	19.4	16.2	17.8	17.8	19.7	24.7	19.0
Erythema-Mild (n=119,124,110,117,106,116,85,99)	20.2	19.4	13.6	17.1	16.0	18.1	24.7	16.2

Population analysed: The safety population included all participants who received at least 1 dose of vaccine;(n)=number of participants with known values.

Primary outcome: Percentage of Participants Reporting Pre-Specified Systemic Events

Time frame: Within 15 days after each dose. Number. Unit: percentage of participants

Measure	13vPnC Dose 1 n = 121	7vPnc Dose 1 n = 126	13vPnC Dose 2 n = 115	7vPnC Dose 2 n = 122	13vPnC Dose 3 n = 110	7vPnC Dose 3 n = 118	13vPnC Toddler Dose n = 86	7vPnC Toddler Dose n = 103
Fv ≥38°C but≤39°C(n=114,121,102,114,100,113,78,94)	16.7	16.5	21.6	24.6	20.0	20.4	14.1	12.8
Fv >39°C but≤40°C(n=113,121,102,113,101,113,77,94)	2.7	0.8	3.9	3.5	2.0	0.9	2.6	0.0
Fv >40°C (n=113,121,102,113,100,113,76,94)	0.0	0.0	0.0	0.0	0.0	0.0	0.0	0.0
Decr. Appetite (n=118,124,110,118,107,117,85,101)	30.5	31.5	22.7	22.9	27.1	30.8	22.4	21.8
Decr. Sleep (n=118,124,110,118,107,117,84,101)	18.6	17.7	24.5	19.5	21.5	18.8	13.1	14.9
Increased Sleep (n=119,124,111,118,107,117,86,101)	56.3	54.0	42.3	46.6	34.6	41.0	27.9	43.6
Irritability (n=118,124,110,118,107,117,85,101)	66.9	71.0	62.7	56.8	51.4	53.8	38.8	47.5
Med.-Prevent Sx (n=95,101,86,96,83,93,85,102)	29.5	33.7	34.9	32.3	36.1	43.0	17.6	35.3

Population analysed: The safety population included all participants who received at least 1 dose of vaccine; (n)=number of participants with known values.

Primary outcome: Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series

Time frame: one month after 3-dose infant series (at 7 months of age). Number (95% Confidence Interval). Unit: percentage of participants

Measure	13vPnC n = 94	7vPnC n = 108
Common Serotypes - Serotype 4 (n=94,107)	96.81 (90.96 to 99.34)	99.07 (94.90 to 99.98)
Common Serotypes - Serotype 6B (n=94,107)	88.30 (80.03 to 94.01)	88.79 (81.23 to 94.07)
Common Serotypes - Serotype 9V (n=94,108)	96.81 (90.96 to 99.34)	99.07 (94.95 to 99.98)
Common Serotypes - Serotype 14 (n=94,107)	97.87 (92.52 to 99.74)	97.20 (92.02 to 99.42)
Common Serotypes - Serotype 18C (n=94,106)	96.81 (90.96 to 99.34)	99.06 (94.86 to 99.98)
Common Serotypes - Serotype 19F (n=94,106)	97.87 (92.52 to 99.74)	97.17 (91.95 to 99.41)
Common Serotypes - Serotype 23F (n=94,108)	94.68 (88.02 to 98.25)	95.37 (89.53 to 98.48)
Additional Serotypes - Serotype 1 (n=94,108)	97.87 (92.52 to 99.74)	25.00 (17.17 to 34.25)

13vPnC vs 7vPnC: Difference: -2.26 (95% CI -8.08 to 2.33)
13vPnC vs 7vPnC: Difference: -0.49 (95% CI -9.93 to 8.65)
13vPnC vs 7vPnC: Difference: -2.27 (95% CI -8.07 to 2.26)

Population analysed: Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)=number of participants with a determinate postinfant series IgG antibody concentration to the given serotype.

12 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
13vPnC Infant Series	9 of 120 (7.5%)	104 of 120 (86.7%)	Not reported
7vPnC Infant Series	9 of 126 (7.1%)	110 of 126 (87.3%)	Not reported
13vPnC Toddler Dose	1 of 86 (1.2%)	33 of 86 (38.4%)	Not reported
7vPnC Toddler Dose	0 of 103 (0%)	51 of 103 (49.5%)	Not reported
13vPnC 6-Month Follow-up	4 of 86 (4.7%)	20 of 86 (23.3%)	Not reported
7vPnC 6-Month Follow-up	1 of 103 (1%)	33 of 103 (32%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20435707Bryant KA, Block SL, Baker SA, Gruber WC, Scott DA; PCV13 Infant Study Group. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine. Pediatrics. 2010 May;125(5):866-75. doi: 10.1542/peds.2009-1405.

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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.

Medical Monitor study director

Wyeth is now a wholly owned subsidiary of Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 11 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 15 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 15 Aug 2012). 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 Reporting Pre-Specified Local Reactions (time frame: Within 15 days after each dose). 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 NCT00205803, 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 15 Aug 2012; AzTrials last refreshed its copy on 31 Oct 2026.