Vaccines, PneumococcalPhase 3NCT00373958

Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine

A Phase 3 study testing 13 valent pneumococcal conjugate vaccine and 7vPnc pneumococcal conjugate vaccine in people with Vaccines, Pneumococcal, run by Pfizer at 37 sites 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, tolerability, and immunogenicity of the 13-valent pneumococcal vaccine (13vPnC) compare to the 7-valent pneumococcal vaccine (7vPnC) and to compare the immune response to concomitant vaccines administered with 13vPnC and 7vPnC. Read more about this study

Who is it for?: Ages 42 to 98 daysHealthy volunteers can take part
Conditions the study is for: Vaccines, Pneumococcal
What is being tested?: 13 valent pneumococcal conjugate vaccine and 7vPnc pneumococcal conjugate vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 666 participants
Where: 37 sitesUnited States
Study dates: Sep 2006to Jun 2008
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 42 to 98 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy 2-month-old infants.
Available for the entire study period.

Who cannot join

Previous vaccination with any vaccine before the start of the study.
Known contraindication to vaccination.

Trial locations and contacts

37 sites in 1 country.

City, postcode or hospital

37 sites in 1 country

United States37 sites

Study site
Bardstown, Kentucky, 40004
Study site
Centennial, Colorado, 80112
Study site
Charleston, South Carolina, 29425
Study site
Chicago, Illinois, 60612
Study site
Cincinnati, Ohio, 45245
Study site
Cleveland, Ohio, 44118
Study site
Downey, California, 90242
Study site
Fayetteville, Arkansas, 72703
Study site
Fontana, California, 92335
Study site
Jackson, Tennessee, 38305
Study site
Jonesboro, Arkansas, 72401
Study site
Latrobe, Pennsylvania, 15650
Study site
Little Rock, Arkansas, 72205
Study site
Loma Linda, California, 92354
Study site
Louisville, Kentucky, 40202
Study site
Louisville, Kentucky, 40207
Study site
Marietta, Georgia, 30062
Study site
Mason, Ohio, 45040
Study site
Murray, Utah, 84107
Study site
Norwich, Connecticut, 06360
Study site
Overland Park, Kansas, 66212
Study site
Paramount, California, 90723
Study site
Park Ridge, Illinois, 60068
Study site
Pittsburgh, Pennsylvania, 15227
Study site
Pittsburgh, Pennsylvania, 15236
Study site
Pittsburgh, Pennsylvania, 15241
Study site
Provo, Utah, 84604
Study site
Richmond, Virginia, 23219
Study site
Riverside, California, 92505
Study site
Rochester, New York, 14620
Study site
Sellersville, Pennsylvania, 18960
Study site
Tampa, Florida, 33606
Study site
The Bronx, New York, 10467
Study site
The Woodlands, Texas, 77380
Study site
Vienna, Virginia, 22180
Study site
Wexford, Pennsylvania, 15090
Study site
Woodstock, Georgia, 30189

Other trials in United States

About this study

Official title: A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability and Immunologic Noninferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United States

Conditions: Vaccines, Pneumococcal
Being tested: 13 valent pneumococcal conjugate vaccine, 7vPnc 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
1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
7vPnc pneumococcal conjugate vaccineBiological
1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.

Study groups in NCT00373958
Study group	Role	What they receive
13vPnC vaccine	Experimental	Not described Receives: Biological: 13 valent pneumococcal conjugate vaccine
7vPnC vaccine	Active comparator	Not described Receives: Biological: 7vPnc pneumococcal conjugate vaccine

What is being measured

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

Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Percentages of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35 μg/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.
Measured: One month after the 3-dose infant series (7 months of age)
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
Antibody concentration/geometric mean concentration 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.
Measured: 1 Month After the Toddler Dose
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Predefined Antibody Levels for Haemophilus Influenzae Type b ([Hib] 0.15 µg/mL or 1.0 µg/mL), Diphtheria Toxoid (0.1 International Units [IU]/mL), and Pertussis antigens (Pertussis filamentous hemagglutinin [FHA] 40.5 Elisa Units [EU]/mL, Pertussis toxoid [PT] 16.5 EU/mL, Pertussis pertactin [PRN] 26 EU/mL).
Measured: One Month After the Infant Series (7 months of age)
Percentage of Participants Reporting Pre-specified Systemic Events
Systemic events (any fever [Fv] ≥ 38 degrees Celsius [C], decreased (decr.) appetite, irritability, increased (incr.) sleep, decreased sleep, and hives [urticaria], use of antipyretic medication [med] to treat or prevent symptoms [sx]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Measured: Within 7 days after each dose
Percentage of Participants Reporting Pre-specified Local Reactions
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant ([Sig.], present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling 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 have been represented in more than 1 category.
Measured: Within 7 days after each dose

Secondary outcomes (6)

Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)
Measured: One month after toddler dose (13 to 16 months of age)
Geometric Mean Antibody Concentration of Hib PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Measured: one month after the toddler dose
Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Normalization was performed for unit of measure "index value" as Index Value of 1.00 = 10 mIU/mL.
Measured: one month after the toddler dose
Geometric Mean Antibody Concentration of Rubella in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Measured: one month after the toddler dose
Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and 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) are presented.
Measured: One month after infant series and one month after toddler dose
Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose
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) are presented.
Measured: one month after the infant series and the toddler dose

Timeline

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

Sep 2006Jun 2008

First posted8 Sep 2006 (estimated)
Study startSep 2006
Primary completionJun 2008
Study completionJun 2008

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 Vaccines, PneumococcalStudies 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: Double blind
Enrolment: 666 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00373958
Sponsor's protocol ID: 6096A1-004
Status last verified: Jan 2013
First submitted: 7 Sep 2006
Last updated: 21 Feb 2013
Results posted: Yes, on ClinicalTrials.gov

Publications

Bryant KA, Gurtman A, Girgenti D, Reisinger K, Johnson A, Pride MW, Patterson S, Devlin C, Gruber WC, Emini EA, Scott DA. Antibody responses to routine pediatric vaccines administered with 13-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2013 Apr;32(4):383-8. doi: 10.1097/INF.0b013e318279e9a9.
PubMed 23104129
Yeh SH, Gurtman A, Hurley DC, Block SL, Schwartz RH, Patterson S, Jansen KU, Love J, Gruber WC, Emini EA, Scott DA; 004 Study Group. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in infants and toddlers. Pediatrics. 2010 Sep;126(3):e493-505. doi: 10.1542/peds.2009-3027. Epub 2010 Aug 23.
PubMed 20732948

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 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability and Immunologic Noninferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United States
ClinicalTrials.gov ID: NCT00373958
Acronym / sponsor ID: 6096A1-004
Conditions: Vaccines, Pneumococcal
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 666 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Sep 2006
Primary completion: Jun 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 8 Sep 2006 (estimated)
Results: Posted 21 Feb 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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
13vPnC vaccine	Experimental	Biological: 13 valent pneumococcal conjugate vaccine
7vPnC vaccine	Active comparator	Biological: 7vPnc pneumococcal conjugate vaccine

Who may qualify

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

Key inclusion criteria (2 listed)

Healthy 2-month-old infants.
Available for the entire study period.

Key exclusion criteria (2 listed)

Previous vaccination with any vaccine before the start of the study.
Known contraindication to vaccination.

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 vaccine1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.	Biological	13vPnC vaccine
7vPnc pneumococcal conjugate vaccine1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.	Biological	7vPnC vaccine

Primary outcome

Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Time frame: One month after the 3-dose infant series (7 months of age)
Percentages of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35 μg/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.
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
Time frame: 1 Month After the Toddler Dose
Antibody concentration/geometric mean concentration 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.
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and 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)
Predefined Antibody Levels for Haemophilus Influenzae Type b ([Hib] 0.15 µg/mL or 1.0 µg/mL), Diphtheria Toxoid (0.1 International Units [IU]/mL), and Pertussis antigens (Pertussis filamentous hemagglutinin [FHA] 40.5 Elisa Units [EU]/mL, Pertussis toxoid [PT] 16.5 EU/mL, Pertussis pertactin [PRN] 26 EU/mL).
Percentage of Participants Reporting Pre-specified Systemic Events
Time frame: Within 7 days after each dose
Systemic events (any fever [Fv] ≥ 38 degrees Celsius [C], decreased (decr.) appetite, irritability, increased (incr.) sleep, decreased sleep, and hives [urticaria], use of antipyretic medication [med] to treat or prevent symptoms [sx]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Percentage of Participants Reporting Pre-specified Local Reactions
Time frame: Within 7 days after each dose
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant ([Sig.], present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling 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 have been represented in more than 1 category.

6 secondary outcomes

Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)
Time frame: One month after toddler dose (13 to 16 months of age)
Geometric Mean Antibody Concentration of Hib PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Time frame: one month after the toddler dose
Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Time frame: one month after the toddler dose
Geometric Mean Antibody Concentration of Rubella in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Time frame: one month after the toddler dose
Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose
Time frame: One month after infant series and one month after toddler dose
Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose
Time frame: one month after the infant series and the toddler dose

Results and safety

Results posted to the registry on 21 Feb 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	334	294
7vPnC	332	290

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

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

Measure	13vPnC n = 252	7vPnC n = 252
Common Serotypes - Serotype 4 (n=252,251)	94.4 (90.9 to 96.9)	98.0 (95.4 to 99.4)
Common Serotypes - Serotype 6B (n=252,250)	87.3 (82.5 to 91.1)	92.8 (88.9 to 95.7)
Common Serotypes - Serotype 9V (n=252,252)	90.5 (86.2 to 93.8)	98.4 (96.0 to 99.6)
Common Serotypes - Serotype 14 (n=251,252)	97.6 (94.9 to 99.1)	97.2 (94.4 to 98.9)
Common Serotypes - Serotype 18C (n=252,252)	96.8 (93.8 to 98.6)	98.4 (96.0 to 99.6)
Common Serotypes - Serotype 19F (n=252,251)	98.0 (95.4 to 99.4)	97.6 (94.9 to 99.1)
Common Serotypes - Serotype 23F (n=252,252)	90.5 (86.2 to 93.8)	94.0 (90.4 to 96.6)
Additional Serotypes - Serotype 1 (n=252,248)	95.6 (92.3 to 97.8)	1.6 (0.4 to 4.1)

13vPnC vs 7vPnC: Difference: -3.6 (95% CI -7.3 to -0.1)
13vPnC vs 7vPnC: Difference: -5.5 (95% CI -10.9 to -0.1)
13vPnC vs 7vPnC: Difference: -7.9 (95% CI -12.4 to -4.0)

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

Primary outcome: Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose

Time frame: 1 Month After the Toddler Dose. Geometric mean (95% Confidence Interval). Unit: μg/mL

Measure	13vPnC n = 239	7vPnC n = 223
Common Serotypes - Serotype 4 (n=235,223)	3.73 (3.28 to 4.24)	5.49 (4.91 to 6.13)
Common Serotypes - Serotype 6B (n=234,223)	11.53 (9.99 to 13.30)	15.63 (13.80 to 17.69)
Common Serotypes - Serotype 9V (n=234,223)	2.62 (2.32 to 2.94)	3.63 (3.25 to 4.05)
Common Serotypes - Serotype 14 (n=235,223)	9.11 (7.95 to 10.45)	12.72 (11.22 to 14.41)
Common Serotypes - Serotype 18C (n=236,223)	3.20 (2.82 to 3.64)	4.70 (4.18 to 5.28)
Common Serotypes - Serotype 19F (n=235,223)	6.60 (5.85 to 7.44)	5.60 (4.87 to 6.43)
Common Serotypes - Serotype 23F (n=234,222)	5.07 (4.41 to 5.83)	7.84 (6.91 to 8.90)
Additional Serotypes - Serotype 1 (n=235,223)	5.06 (4.43 to 5.80)	0.03 (0.03 to 0.03)

13vPnC vs 7vPnC: Ratio: 0.68 (95% CI 0.57 to 0.80)
13vPnC vs 7vPnC: Ratio: 0.74 (95% CI 0.61 to 0.89)
13vPnC vs 7vPnC: Ratio: 0.72 (95% CI 0.62 to 0.85)

Population analysed: Evaluable immunogenicity (per protocol) population of eligible participants, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration for the specified serotype.

Primary outcome: Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and 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). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	13vPnC n = 252	7vPnC n = 252
Hib 0.15 µg/mL (n=237,230)	97.9 (95.1 to 99.3)	97.8 (95.0 to 99.3)
Hib 1.0 µg/mL (n=237,230)	77.6 (71.8 to 82.8)	78.3 (72.4 to 83.4)
Diphtheria [IU]/mL (n=233,230)	95.7 (92.2 to 97.9)	96.1 (92.7 to 98.2)
FHA [EU]/mL (n=239,240)	96.7 (93.5 to 98.5)	95.0 (91.4 to 97.4)
PT [EU]/mL (n=239,240)	94.1 (90.4 to 96.8)	95.0 (91.4 to 97.4)
PRN [EU]/mL (n=239,240)	93.7 (89.9 to 96.4)	95.8 (92.5 to 98.0)

13vPnC vs 7vPnC: Difference: 0.1 (95% CI -2.9 to 3.1)
13vPnC vs 7vPnC: Difference: -0.6 (95% CI -8.3 to 7.0)
13vPnC vs 7vPnC: Difference: -0.4 (95% CI -4.3 to 3.5)

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

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

Time frame: Within 7 days after each dose. Number. Unit: Percentage of participants

Measure	13vPnC Dose 1 n = 332	7vPnC Dose 1 n = 331	13vPnC Dose 2 n = 309	7vPnC Dose 2 n = 305	13vPnC Dose 3 n = 298	7vPnC Dose 3 n = 300	13vPnC Toddler Dose n = 272	7vPnC Toddler Dose n = 265
Fv≥38°C but ≤39°C(n=196,203,146,151,123,106,99,76	24.0	21.2	43.2	40.4	39.8	37.7	53.5	51.3
Fv>39°C but ≤40°C(n=177,187,118,123,94,81,61,48)	2.8	0.0	2.5	4.9	8.5	2.5	6.6	12.5
Fv >40°C (n=174,187,116,121,87,80,60,45)	0.0	0.0	0.0	0.8	0.0	1.3	1.7	0.0
Decr. appetite (n=228,238,177,174,147,136,116,110)	54.8	45.4	59.9	52.3	59.2	59.6	65.5	73.6
Irritability (n=289,290,236,236,216,218,199,175)	89.6	85.9	89.8	91.5	88.4	92.2	92.0	93.1
Incr. sleep (n=268,270,203,200,164,149,115,109)	79.5	78.5	79.3	73.5	71.3	69.8	70.4	74.3
Decr. sleep (n=221,236,169,172,154,134,113,95)	45.7	47.9	49.1	55.8	60.4	63.4	58.4	64.2
Hives (urticaria) (n=178,188,118,120,89,79,62,47)	1.7	1.1	2.5	0.0	4.5	0.0	4.8	6.4

Population analysed: Safety population who received the given vaccination. (n)= number of participants reporting yes for at least 1 day or no for all days.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected throughout the study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
13vPnC Infant Series	17 of 332 (5.1%)	272 of 332 (81.9%)	Not reported
7vPnC Infant Series	16 of 331 (4.8%)	263 of 331 (79.5%)	Not reported
13vPnC Post Infant Series	5 of 332 (1.5%)	31 of 332 (9.3%)	Not reported
7vPnC Post Infant Series	7 of 330 (2.1%)	29 of 330 (8.8%)	Not reported
13vPnC Toddler Series	3 of 267 (1.1%)	183 of 267 (68.5%)	Not reported
7vPnC Toddler Series	4 of 258 (1.6%)	163 of 258 (63.2%)	Not reported
13vPnC 6-Month Follow-up	9 of 330 (2.7%)	11 of 330 (3.3%)	Not reported
7vPnC 6-Month Follow-up	5 of 329 (1.5%)	10 of 329 (3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23104129Bryant KA, Gurtman A, Girgenti D, Reisinger K, Johnson A, Pride MW, Patterson S, Devlin C, Gruber WC, Emini EA, Scott DA. Antibody responses to routine pediatric vaccines administered with 13-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2013 Apr;32(4):383-8. doi: 10.1097/INF.0b013e318279e9a9.
Derived from this study: PubMed 20732948Yeh SH, Gurtman A, Hurley DC, Block SL, Schwartz RH, Patterson S, Jansen KU, Love J, Gruber WC, Emini EA, Scott DA; 004 Study Group. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in infants and toddlers. Pediatrics. 2010 Sep;126(3):e493-505. doi: 10.1542/peds.2009-3027. Epub 2010 Aug 23.

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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

37 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 and 7vPnc pneumococcal conjugate vaccine in people with Vaccines, Pneumococcal, run by Pfizer at 37 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 2 inclusion and 2 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 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 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 21 Feb 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?

Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series (time frame: One month after the 3-dose infant series (7 months of age)). The study lists 5 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 NCT00373958, 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 Feb 2013.