Vaccines, PneumococcalPhase 3NCT00384059

Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

A Phase 3 study testing 13-valent Pneumococcal Conjugate Vaccine, 7vPnC and Pediacel in people with Vaccines, Pneumococcal, run by Wyeth is now a wholly owned subsidiary of Pfizer at 11 sites in United Kingdom.

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 assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccines in the United Kingdom. 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, 7vPnC and Pediacel
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 286 participants
Where: 11 sitesUnited Kingdom
Study dates: Oct 2006to Oct 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

Aged 2 months (42 to 98 days) at the time of enrollment.
Available for entire study period and whose parent(s)/legal guardian(s) could be reached by telephone.
Healthy infant, as determined by medical history, physical examination, and judgment of the investigator.
Parent(s)/legal guardian(s) had to be able to complete all relevant study procedures during study participation.

Who cannot join

Previous vaccination with licensed or investigational pneumococcal vaccine.
Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or meningococcal vaccines.
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, pneumococcal conjugate, or meningococcal conjugate vaccines.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
Known or suspected immune deficiency or suppression.

Show all 12Show fewer

History of culture-proven invasive disease caused by S pneumoniae, Neisseria meningitidis, or Hib.
Major known congenital malformation or serious chronic disorder.
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. This did not include resolving syndromes due to birth trauma such as Erb palsy.
Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®).
Participation in another investigational trial. Participation in purely observational studies was acceptable.
Infant who was a direct descendant (eg, child or grandchild) of the study site personnel.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United Kingdom11 sites

Study site
Atherstone, CV9 1EU
Study site
Bangor, BT19 1NB
Study site
Bristol, BS2 8AE
Study site
Co Antrim, BT41 3AE
Study site
Coventry, CV6 4DD
Study site
Ely, CB7 4HF
Study site
London, SW17 ORE
Study site
Oxford, OX3 9DU
Study site
Plymouth, PL5 3JB
Study site
Southampton, SO16 6YD
Study site
Weston-super-Mare, BS22 6AJ

Other trials in United Kingdom

About this study

Official title: A Phase 3, Randomized, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United Kingdom

Conditions: Vaccines, Pneumococcal
Being tested: 13-valent Pneumococcal Conjugate Vaccine, 7vPnC, Pediacel, NeisVac-C, Menitorix

What participants receive

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

13-valent Pneumococcal Conjugate VaccineBiological
Single 0.5 mL dose given at 2, 3, 4, and 12 months of age
7vPnCBiological
Single 0.5 mL dose given at 2, 3, 4 and 12 months of age
PediacelBiological
concommitant vaccine, both at arm 1 and at arm 2, at 2 months, 3 months and 4 months of age
NeisVac-CBiological
concomittant vaccine, both at arm 1 and at arm 2, at 2 months and 4 months of age
MenitorixBiological
concomitant vaccine, both at arm 1 and at arm 2, at 12 months of age

Study groups in NCT00384059
Study group	Role	What they receive
1	Experimental	13-valent pneumococcal vaccine Receives: Biological: 13-valent Pneumococcal Conjugate Vaccine; Biological: Pediacel; Biological: NeisVac-C; Biological: Menitorix
2	Active comparator	7-valent pneumococcal vaccine Receives: Biological: 7vPnC; Biological: Pediacel; Biological: NeisVac-C; Biological: Menitorix

What is being measured

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

Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series.
Percentage of participants achieving a meningococcal C SBA serum antibody titer ≥1:8 and predefined antibody threshold levels with the corresponding 95% CI for concomitant antigens polyribosylribitol phosphate (PRP) in haemophilus influenzae type b [Hib](≥0.15 μg/mL or ≥ 1.0 μg/mL), pertussis toxoid [PT], filamentous haemagglutinin, pertactin [FHA], and pertactin (PRN) (≥5 Elisa Units EU/mL) and fimbrial agglutinogens [FIM] (≥2.2 EU/mL) are presented.
Measured: One month after infant series dose 2 (5 months of age)
Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series
Measured: one month after infant series dose 2 (5 months of age)
Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series
Measured: one month after infant series dose 2 (5 months of age)
Geometric Mean Antibody Concentration of Pertusis Filamentous Haemagglutinin (FHA), Pertussis Toxoid (PT), Pertactin (PRN), and Fimbrial Agglutinogens (FIM) as Measured by ELISA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series
Measured: one month after infant series dose 2 (5 months of age)
Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and 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.
Measured: one month after infant series dose 2 (5 months of age), before and after toddler dose (12 months of age)
Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose.
Antibody concentration/geometric mean concentration (GMC) as measured by 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 with corresponding 2-sided 95% CI.
Measured: one month after infant series dose 2 (5 months of age) and before and after toddler dose (12 months of age)

Secondary outcomes (4)

Percentage of Participants Achieving an SBA Titer ≥1:8 for Meningococcal C in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose.
Measured: one month after the toddler dose (13 months of age)
Percentage of Participants Achieving a Predefined Antibody Level for Haemophilus Influenzae Type b in the 13vPnC Group Relative to the 7vPnC Group After the Toddler Dose.
Measured: one month after toddler dose (13 months of age)
Geometric Mean Antibody Concentration for Haemophilus Influenzae Type b PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose.
Measured: one month after toddler dose (13 months of age)
Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Measured: one month after toddler dose (13 months of age)

Timeline

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

Oct 2006Oct 2008

First posted4 Oct 2006 (estimated)
Study startOct 2006
Primary completionOct 2008
Study completionOct 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.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 286 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00384059
Sponsor's protocol ID: 6096A1-007
Status last verified: Jan 2013
First submitted: 2 Oct 2006
Last updated: 24 Jan 2013
Results posted: Yes, on ClinicalTrials.gov

Publications

Rodgers GL, Esposito S, Principi N, Gutierrez-Brito M, Diez-Domingo J, Pollard AJ, Snape MD, Martinon-Torres F, Gruber WC, Patterson S, Thompson A, Gurtman A, Paradiso P, Scott DA. Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule. Vaccine. 2013 Oct 1;31(42):4765-74. doi: 10.1016/j.vaccine.2013.08.009. Epub 2013 Aug 16.
PubMed 23965217
Snape MD, Klinger CL, Daniels ED, John TM, Layton H, Rollinson L, Pestridge S, Dymond S, Galiza E, Tansey S, Scott DA, Baker SA, Jones TR, Yu LM, Gruber WC, Emini EA, Faust SN, Finn A, Heath PT, Pollard AJ. Immunogenicity and reactogenicity of a 13-valent-pneumococcal conjugate vaccine administered at 2, 4, and 12 months of age: a double-blind randomized active-controlled trial. Pediatr Infect Dis J. 2010 Dec;29(12):e80-90. doi: 10.1097/inf.0b013e3181faa6be.
PubMed 21155091

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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Study at a glance

From the registry record, last updated by the sponsor on 24 Jan 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 Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United Kingdom
ClinicalTrials.gov ID: NCT00384059
Acronym / sponsor ID: 6096A1-007
Conditions: Vaccines, Pneumococcal
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 286 participants (actual)
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Study start: Oct 2006
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 4 Oct 2006 (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: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Biological: 13-valent Pneumococcal Conjugate Vaccine, Biological: Pediacel, Biological: NeisVac-C, Biological: Menitorix13-valent pneumococcal vaccine
2	Active comparator	Biological: 7vPnC, Biological: Pediacel, Biological: NeisVac-C, Biological: Menitorix7-valent pneumococcal vaccine

Who may qualify

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

Key inclusion criteria (4 listed)

Aged 2 months (42 to 98 days) at the time of enrollment.
Available for entire study period and whose parent(s)/legal guardian(s) could be reached by telephone.
Healthy infant, as determined by medical history, physical examination, and judgment of the investigator.
Parent(s)/legal guardian(s) had to be able to complete all relevant study procedures during study participation.

Key exclusion criteria (12 listed)

Previous vaccination with licensed or investigational pneumococcal vaccine.
Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or meningococcal vaccines.
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, pneumococcal conjugate, or meningococcal conjugate vaccines.
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 VaccineSingle 0.5 mL dose given at 2, 3, 4, and 12 months of age	Biological	1
7vPnCSingle 0.5 mL dose given at 2, 3, 4 and 12 months of age	Biological	2
Pediacelconcommitant vaccine, both at arm 1 and at arm 2, at 2 months, 3 months and 4 months of age	Biological	1, 2
NeisVac-Cconcomittant vaccine, both at arm 1 and at arm 2, at 2 months and 4 months of age	Biological	1, 2
Menitorixconcomitant vaccine, both at arm 1 and at arm 2, at 12 months of age	Biological	1, 2

Primary outcome

Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series.
Time frame: One month after infant series dose 2 (5 months of age)
Percentage of participants achieving a meningococcal C SBA serum antibody titer ≥1:8 and predefined antibody threshold levels with the corresponding 95% CI for concomitant antigens polyribosylribitol phosphate (PRP) in haemophilus influenzae type b [Hib](≥0.15 μg/mL or ≥ 1.0 μg/mL), pertussis toxoid [PT], filamentous haemagglutinin, pertactin [FHA], and pertactin (PRN) (≥5 Elisa Units EU/mL) and fimbrial agglutinogens [FIM] (≥2.2 EU/mL) are presented.
Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series
Time frame: one month after infant series dose 2 (5 months of age)
Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series
Time frame: one month after infant series dose 2 (5 months of age)
Geometric Mean Antibody Concentration of Pertusis Filamentous Haemagglutinin (FHA), Pertussis Toxoid (PT), Pertactin (PRN), and Fimbrial Agglutinogens (FIM) as Measured by ELISA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series
Time frame: one month after infant series dose 2 (5 months of age)
Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose
Time frame: one month after infant series dose 2 (5 months of age), before and after toddler dose (12 months of age)
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.
Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose.
Time frame: one month after infant series dose 2 (5 months of age) and before and after toddler dose (12 months of age)
Antibody concentration/geometric mean concentration (GMC) as measured by 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 with corresponding 2-sided 95% CI.

4 secondary outcomes

Percentage of Participants Achieving an SBA Titer ≥1:8 for Meningococcal C in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose.
Time frame: one month after the toddler dose (13 months of age)
Percentage of Participants Achieving a Predefined Antibody Level for Haemophilus Influenzae Type b in the 13vPnC Group Relative to the 7vPnC Group After the Toddler Dose.
Time frame: one month after toddler dose (13 months of age)
Geometric Mean Antibody Concentration for Haemophilus Influenzae Type b PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose.
Time frame: one month after toddler dose (13 months of age)
Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Time frame: one month after toddler dose (13 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	141	135
7vPnC	145	132

Primary outcome: Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series.

Time frame: One month after infant series dose 2 (5 months of age). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	13vPnC n = 120	7vPnC n = 118
Meningococcal C ≥ 1:8 titer (n=120,118)	99.2 (95.4 to 100.0)	99.2 (95.4 to 100.0)
Hib (PRP) ≥ 0.15 μg/mL (n=114,102)	96.5 (91.3 to 99.0)	98.0 (93.1 to 99.8)
Hib (PRP) ≥ 1.0 μg/mL (n=114,102)	85.1 (77.2 to 91.1)	89.2 (81.5 to 94.5)
Pertussis PT ≥ 5 EU/mL (n=119,112)	100.0 (96.9 to 100.0)	100.0 (96.8 to 100.0)
Pertussis PT ≥ 17 EU/mL (n=119,112)	96.6 (91.6 to 99.1)	95.5 (89.9 to 98.5)
Pertussis FHA ≥ 5 EU/mL (n=119,113)	100.0 (96.9 to 100.0)	100.0 (96.8 to 100.0)
Pertussis FHA ≥ 7.82 EU/mL (n=119,113)	100.0 (96.9 to 100.0)	100.0 (96.8 to 100.0)
Pertussis FHA ≥ 20 EU/mL (n=119,113)	94.1 (88.3 to 97.6)	95.6 (90.0 to 98.5)

13vPnC vs 7vPnC: Difference: 0.0 (95% CI -3.8 to 3.9)
13vPnC vs 7vPnC: Difference: -1.5 (95% CI -7.1 to 3.7)
13vPnC vs 7vPnC: Difference: -4.1 (95% CI -13.4 to 5.1)

Population analysed: Evaluable immunogenicity (per protocol) population consisting of eligible 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 postinfant series antibody concentration to the given concomitant antigen.

Primary outcome: Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series

Time frame: one month after infant series dose 2 (5 months of age). Geometric mean (95% Confidence Interval). Unit: titer

Measure	13vPnC n = 120	7vPnC n = 118
Value	306.20 (251.21 to 373.22)	345.42 (287.91 to 414.41)

13vPnC vs 7vPnC: Ratio: 0.89 (95% CI 0.68 to 1.16)

Population analysed: Evaluable immunogenicity (per protocol) population consisting of eligible 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 antibody concentration/titer for the specified concomitant antigen.

Primary outcome: Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series

Time frame: one month after infant series dose 2 (5 months of age). Geometric mean (95% Confidence Interval). Unit: μg/mL

Measure	13vPnC n = 114	7vPnC n = 102
Value	3.40 (2.65 to 4.37)	4.44 (3.50 to 5.63)

13vPnC vs 7vPnC: Ratio: 0.77 (95% CI 0.54 to 1.08)

Population analysed: Evaluable immunogenicity (per protocol) population consisting of eligible 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 antibody concentration/titer for the specified concomitant antigen.

Primary outcome: Geometric Mean Antibody Concentration of Pertusis Filamentous Haemagglutinin (FHA), Pertussis Toxoid (PT), Pertactin (PRN), and Fimbrial Agglutinogens (FIM) as Measured by ELISA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series

Time frame: one month after infant series dose 2 (5 months of age). Geometric mean (95% Confidence Interval). Unit: EU/mL

Measure	13vPnC n = 120	7vPnC n = 118
Pertussis FHA (n=119,113)	54.74 (48.25 to 373.22)	55.99 (49.55 to 414.41)
Pertussis PT (n=119,112)	66.26 (59.20 to 74.16)	67.05 (58.75 to 76.52)
Pertussis PRN (n=119,113)	61.33 (51.78 to 72.65)	61.07 (52.31 to 71.30)
Pertussis FIM (n=119,113)	21.72 (18.89 to 24.98)	21.77 (18.54 to 25.56)

13vPnC vs 7vPnC: Ratio: 0.98 (95% CI 0.82 to 1.16)
13vPnC vs 7vPnC: Ratio: 0.99 (95% CI 0.83 to 1.17)
13vPnC vs 7vPnC: Ratio: 1.00 (95% CI 0.80 to 1.26)

Population analysed: Evaluable immunogenicity (per protocol) population consisting of eligible 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 antibody concentration/titer for the specified concomitant antigen.

4 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	1 of 139 (0.7%)	111 of 138 (80.4%)	Not reported
7vPnC Infant Series	3 of 139 (2.2%)	105 of 139 (75.5%)	Not reported
13vPnC Post-Infant Series	5 of 139 (3.6%)	9 of 138 (6.5%)	Not reported
7vPnC Post-Infant Series	2 of 139 (1.4%)	8 of 139 (5.8%)	Not reported
13vPnC Toddler Series	1 of 131 (0.8%)	72 of 130 (55.4%)	Not reported
7vPnC Toddler Series	2 of 122 (1.6%)	61 of 122 (50%)	Not reported
13vPnC 6-Month Follow-up	2 of 138 (1.4%)	1 of 138 (0.7%)	Not reported
7vPnC 6-Month Follow-up	0 of 139 (0%)	1 of 139 (0.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23965217Rodgers GL, Esposito S, Principi N, Gutierrez-Brito M, Diez-Domingo J, Pollard AJ, Snape MD, Martinon-Torres F, Gruber WC, Patterson S, Thompson A, Gurtman A, Paradiso P, Scott DA. Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule. Vaccine. 2013 Oct 1;31(42):4765-74. doi: 10.1016/j.vaccine.2013.08.009. Epub 2013 Aug 16.
Derived from this study: PubMed 21155091Snape MD, Klinger CL, Daniels ED, John TM, Layton H, Rollinson L, Pestridge S, Dymond S, Galiza E, Tansey S, Scott DA, Baker SA, Jones TR, Yu LM, Gruber WC, Emini EA, Faust SN, Finn A, Heath PT, Pollard AJ. Immunogenicity and reactogenicity of a 13-valent-pneumococcal conjugate vaccine administered at 2, 4, and 12 months of age: a double-blind randomized active-controlled trial. Pediatr Infect Dis J. 2010 Dec;29(12):e80-90. doi: 10.1097/inf.0b013e3181faa6be.

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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

Trial Manager principal investigator

For UK/Great Britian, ukmedinfo@wyeth.com

11 sites 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 4 inclusion and 12 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 24 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 11 sites in United Kingdom. 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 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 Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series. (time frame: One month after infant series dose 2 (5 months of age)). The study lists 6 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 NCT00384059, 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 24 Jan 2013.