Booster vaccination of infants aims to further reduce the burden of childhood infectious diseases. This study assessed the antibody persistence induced by a primary series vaccination at 2, 4, 6 months of age and a first booster at 18-19 months of age with a pentavalent diphtheria, tetanus, acellular pertussis, inactivated poliovirus, Haemophilus influenzae type b combined vaccine (DTaP-IPV//PRP-T) in 4-6 year-old Thai children (N=123). The safety and immunogenicity of a tetravalent acellular pertussis combined vaccine (containing the same DTaP-IPV antigens as the previous vaccine) given as a second booster at 4 to 6 years of age was also evaluated. Seroprotective antibody levels against diphtheria (> or = 0.01 IU/ml), tetanus (> or = 0.10 IU/ml), and polioviruses (> or = 8 1/dil) were maintained 4-6 years after primary-vaccination and first booster by > or = 92.7% of children, and anti-pertussis antibodies > or = 5 EU/ml were observed in the majority of children. The second booster with DTaP-IPV elicited a strong response for all antigens. GMT or GMC ratios for all antigens at the pre- and post-booster samples were from 4.7 to 52.5. Primary vaccination at 2, 4, 6 and a booster at 18-19 months of age with the DTaP-IPV//PRP-T vaccine induced satisfactory antibody persistence at 4-6 years of age. A second booster with DTaP-IPV induced a strong immune response and was well tolerated.

High vaccination coverage in children by age 2 years has resulted in historically low levels of most vaccine-preventable diseases in the United States, but coverage must be maintained to reduce the burden of disease further and prevent a resurgence of these diseases, particularly in populations with lower vaccination coverage. This report describes national, state, and selected local area vaccination coverage by age 19-35 months for children born during January 2008-May 2010, based on 2011 National Immunization Survey (NIS) results. Vaccination coverage remained above the national Healthy People 2020 target* of 90% for ≥1 dose measles, mumps, rubella vaccine (MMR) (91.6%), ≥3 doses of hepatitis B vaccine (HepB) (91.1%), ≥3 doses of poliovirus vaccine (93.9%), and ≥1 dose of varicella vaccine (90.8%). For the birth dose of HepB, coverage increased from 64.1% in 2010 to 68.6% in 2011; for the more recently recommended ≥2 doses of hepatitis A vaccine (HepA) and rotavirus vaccines, coverage increased from 49.7% to 52.2% and from 59.2% to 67.3%, respectively; and for the full series of Haemophilus influenzae type b vaccine (Hib), coverage increased from 66.8% to 80.4%, reflecting recovery from the Hib shortage that occurred during December 2007-September 2009. The percentage of children who had not received any vaccinations remained at <1%. Children living below the poverty level had lower coverage than children living at or above poverty for ≥4 doses of diphtheria, tetanus toxoid, and acellular pertussis vaccine (DTaP) and ≥4 doses of pneumococcal conjugate vaccine (PCV) (by 6 percentage points each); the full Hib series (by 8 percentage points); and for rotavirus vaccination (by 10 percentage points). Continued partnerships among national, state, local, private, and public entities are needed to sustain current coverage levels and ensure that coverage for the more recently recommended vaccines continues to increase for all children.

Infanrix hexa™, a diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis, and Haemophilus influenzae type b (Hib) conjugate vaccine, is indicated for primary and booster vaccination of infants. Available clinical data from more than a decade of experience with the vaccine indicate that primary and booster vaccination with Infanrix hexa™ is a safe and useful option for providing protection against the common childhood diseases of diphtheria, tetanus, poliomyelitis, pertussis, hepatitis B, and disease caused by Hib.

This study compared the safety and immunogenicity of DTaP₅-IPV-Hib vaccine (followed by monovalent hepatitis B vaccine [HBV]) and DTaP₃-HBV-IPV/Hib vaccines, both coadministered with PCV7, as a fourth-dose booster in toddlers 11-18 months who had a hexavalent vaccine primary series. The fever rate within 4 days of DTaP₅-IPV-Hib was noninferior to DTaP₃-HBV-IPV/Hib. DTaP₅-IPV-Hib induced a marked immune response and had a similar safety and immunogenicity profile compared with DTaP₃-HBV-IPV/Hib. Fully liquid DTaP₅-IPV-Hib can be used as a booster after a hexavalent vaccine primary series; where required, a fourth dose of monovalent HBV can be administered after DTaP₅-IPV-Hib (NCT ID: NCT00355654).

In India, pneumococcal diseases are major causes of child mortality, and effective vaccines against Streptococcus pneumoniae are needed. This single-blind, randomized study assessed the immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Hemophilus influenzae (NTHi) protein D conjugate vaccine (PHiD-CV) co-administered with DTPw-HBV/Hib in Indian infants as 3-dose primary vaccination course. A total of 360 infants were randomized (2:1) to receive either PHiD-CV co-administered with DTPw-HBV/Hib (PHiD-CV group) or a Hib vaccine co-administered with DTPw-HBV (control group) at 6, 10, and 14 weeks of age. For each vaccine pneumococcal serotype, the percentage of infants in the PHiD-CV group with antibody concentrations ≥ 0.2 µg/mL one month after the third vaccine dose was at least 98.3%, except for serotypes 6B (77.7%) and 23F (89.5%), and opsonophagocytic activity titers ≥ 8 were measured in at least 95.7% of infants, except for serotypes 1 (90.5%) and 6B (84.5%). In addition, all the infants in the PHiD-CV group were seroprotected against diphtheria, tetanus, Hib, and hepatitis B or seropositive for antibodies against pertussis and NTHi protein D (except one infant). Incidences of solicited local and general symptoms were comparable between groups, except for fever (axillary temperature ≥ 37.5°C), which seemed to occur more frequently in the PHiD-CV group. In conclusion, PHiD-CV was shown to be immunogenic and well-tolerated when co-administered with DTPw-HBV/Hib in Indian infants.

Haemophilus influenzae type b (Hib) carriage and disease studies in Nepali children suggest a significant burden of infection. Hib conjugate vaccines (HibCV) do not have uniform immunogenicity between populations. We determined the immunogenicity of HibCV in Nepali infants, before its introduction into the routine immunization schedule.Ninety infants recruited at Patan Hospital, Kathmandu, received 3 doses of the HibCV with routine immunizations (diphtheria, tetanus, whole cell pertussis-hepatitis B vaccine + oral polio vaccine) at 6, 10 and 14 weeks of age, and a HibCV booster at 52 weeks. Anti-polyribosylribitol phosphate (PRP) concentrations were measured at 18, 52 and 56 weeks, and the antibody persistence at 52 weeks was compared with antibody values in unimmunized controls (n = 30).After 3 doses of primary immunizations, at 18 weeks of age (n = 74), all infants had anti-PRP concentrations above the accepted thresholds for short- and long-term protection (0.15 and 1.0 µg/mL, respectively). At 1 year of age, before administration of the booster of HibCV, the anti-PRP geometric mean antibody concentration was 2.76 µg/mL (confidence interval: 1.88-4.07) in sera from the immunized children compared with 0.11 µg/mL (95% confidence interval: 0.08-0.17) in the nonimmunized control group (n = 30). Twenty-seven percent (20/74) of participants, however, had anti-PRP concentrations <1.0 µg/mL. Four weeks after the booster dose of HibCV, 98.5% of infants had anti-PRP concentrations above 1.0 µg/mL.Immunization with HibCV given as part of the Expanded Program on Immunization schedule in Nepal elicits robust antibody responses. Though the antibody wanes during the first year of life, most 1-year-old infants remain protected and respond robustly to a booster dose of the vaccine.

As multiple vaccines are administered concomitantly during routine pediatric immunizations, it is important to ascertain the potential interference of any new vaccine on the immune response to the concomitantly administered vaccines. Immune responses to meningococcal serogroup C-tetanus toxoid conjugate vaccine (MnCC-TT) and the diphtheria and tetanus antigens in routine pediatric vaccines (diphtheria, tetanus, acellular pertussis-hepatitis B virus-inactivated poliovirus/Haemophilus influenza type b [DTaP-HBV-IPV/Hib] and DTaP-IPV+Hib) when given concomitantly with the 13-valent pneumococcal conjugate vaccine (PCV13) were compared with responses when given with PCV7. In addition, the immunogenicity and safety of PCV13 were assessed.Healthy infants were randomized to receive PCV13 or PCV7 (ages 2, 4, 6 and 15 months), concomitant with MnCC-TT (2, 4 and 15 months), DTaP-HBV-IPV/Hib (2, 4 and 6 months), and DTaP-IPV+Hib (15 months).Immune responses to MnCC-TT and to the diphtheria and tetanus antigens administered with PCV13 were noninferior to the responses observed when the vaccines were administered with PCV7; ≥96.6 (postinfant) and ≥99.4% (posttoddler) subjects achieved prespecified immune response levels to each antigen in each group. After the infant series, ≥93.0% of subjects receiving PCV13 achieved pneumococcal anticapsular immunoglobulin G concentrations ≥0.35 µg/mL for all serotypes except serotype 3 (86.2%), increasing to 98.1-100% for most serotypes (serotype 3: 93.6%) after the toddler dose. Local and systemic reactions were similar between groups.Immune responses to MnCC-TT, and other childhood vaccines (DTaP-HBV-IPV/Hib, DTaP-IPV+Hib) were noninferior when concomitantly administered with PCV13 compared with PCV7. PCV13 does not interfere with MnCC-TT. PCV13 is highly immunogenic with a favorable safety profile.

To assess the immunogenicity and safety of a pentavalent diphtheria, tetanus, acellular pertussis, inactivated poliovirus, Hib polysaccharide-conjugate vaccine booster.A DTaP-IPV//PRP~T vaccine (Pentaxim, a Sanofi Pasteur AcXim family vaccine) was given to 182 healthy children in South Africa at 18 - 19 months of age following priming with the same vaccine plus a monovalent hepatitis B vaccine at 6, 10 and 14 weeks of age. Outcome measures. Seroprotection (SP) and seroconversion (SC) rates, geometric mean titres (GMTs) and concentrations (GMCs) were assessed before, and 1 month after, the booster dose. Safety was assessed using parental reports.One month after primary vaccination, at least 94.3% of participants were seroprotected against tetanus (≥ 0.01 IU/ml), diphtheria (≥ 0.01 IU/ml), poliovirus (≥ 8 1/dil) and Haemophilus influenzae type b (Hib) infection (≥ 0.15 µg/ml). Before the booster dose, the SP rates ranged from 65.7% to 100%. One month after the booster dose, SP rates were 97.7% for Hib (anti-PRP titre 1.0 μg/ml), 100.0% for diphtheria (≥ 0.1 IU/ml) and 100% for tetanus (≥ 0.1 IU/ml) and poliovirus types 1, 2, 3 (≥ 8 1/dil). At least 95.7% of participants had 4 fold post-booster increases in anti-pertussis antibody titres. GMTs increased from 11.21 to 465.51 EU/ml and from 12.89 to 520.35 EU/ml for anti-PT and anti-FHA respectively. Anti-PRP GMT increased from 0.35 to 47.01 μg/ml. The DTaP-IPV//PRP~T vaccine booster was well tolerated, with fever ≥ 39.0°C in only 1.7% of participants.Antibody persistence following priming was satisfactory. The pentavalent DTaP-IPV//PRP~T vaccine booster was highly immunogenic and well tolerated.

Immunization quality improvement (QI) interventions are rarely tested as multicomponent interventions within the context of a theoretical framework proven to improve outcomes. Our goal was to study a comprehensive QI program to increase immunization rates for underserved children that relied on recommendations from the Centers for Disease Control and Prevention's Task Force on Community Preventive Services and the framework of the Chronic Care Model.QI activities occurred from September 2007 to May 2008 at 6 health centers serving a low-income, minority population in Washington, DC. Interventions included family reminders, education, expanding immunization access, reminders and feedback for providers, and coordination of activities with community stakeholders. We determined project effectiveness in improving the 4:3:1:3:3:1:3 vaccination series (4 diphtheria-tetanus-pertussis vaccines, 3 poliovirus vaccines, 1 measles-mumps-rubella vaccine, 3 Haemophilus influenzae type b vaccines, 3 hepatitis B vaccines, 1 varicella vaccine, and three 7-valent pneumococcal conjugate vaccines) compliance.We found a 16% increase in immunization rates overall and a 14% increase in on-time immunization by 24 months of age. Improvement was achieved at all 6 health centers and maintained beyond 18 months.We were able to implement a comprehensive immunization QI program that was sustainable over time.

Pediacel® is a fully liquid formulation of a diphtheria, tetanus, five-component acellular pertussis, inactivated poliovirus and Haemophilus influenzae type b combination vaccine, which does not require reconstitution. Both vial and prefilled syringe presentations of Pediacel® are available for use in the EU. In active-controlled clinical trials, primary and/or booster vaccination with Pediacel® was highly immunogenic, eliciting strong and sustained serologic responses against all its component toxoids/antigens when administered according to a variety of different schedules. In particular, pivotal studies showed that Pediacel® was generally similar and/or noninferior to reconstituted pentavalent and hexavalent diphtheria, tetanus, and acellular pertussis-based combination vaccines in terms of the seroprotection rates elicited against the diphtheria, tetanus, poliovirus, and Haemophilus influenzae type b components that these products have in common, as well as in terms of the seroresponse/booster response rates elicited against the acellular pertussis components that these products have in common. Differences in immune responses between Pediacel® and these vaccines were considered unlikely to be clinically significant. There was no clear evidence of clinically relevant changes in the immunogenicity of Pediacel® (or the coadministered vaccine) when given concomitantly with meningococcal group C conjugate, pneumococcal conjugate, or hepatitis B vaccines in clinical studies. Pediacel® was generally well tolerated and demonstrated low reactogenicity in clinical trials. It had an adverse event profile generally similar to that of other combination vaccines based on diphtheria, tetanus and acellular pertussis vaccine, including Infanrix®-IPV+Hib and Infanrix® hexa.